NATIONAL INSTITUTE FOR CLINICAL

EXCELLENCE
INTERVENTIONAL PROCEDURES PROGRAMME
Interventional procedures overview of wireless
capsule endoscopy
Introduction
This overview has been prepared to assist members of the Interventional Procedures
Advisory Committee in making recommendations about the safety and efficacy of an
interventional procedure. It is based on a rapid review of the medical literature and
specialist opinion. It should not be regarded as a definitive assessment of the
procedure.
Date prepared
This overview was prepared in January 2004.
Procedure name
Wireless capsule endoscopy.
Video capsule endocscopy.
Specialty societies
British Society of Interventional Radiology.
Association of Upper Gastrointestinal Surgeons of Great Britain and Ireland.
British Society of Gastroenterology.
Description
Indications
Gastrointestinal bleeding and suspected Crohns disease
Obscure gastro-intestinal bleeding is defined as bleeding of unknown origin that
persists or recurs after a negative initial or primary endoscopy (colonoscopy and/or
upper endoscopy). Diagnosis may be difficult because often bleeding can be slow
and/or intermittent. Patients may experience prolonged blood loss, leading to iron
deficiency (anaemia) and a feeling of fatigue and or weariness.
A common source of gastrointestinal bleeding is the small intestine. This can result
from several causes. The most common of these causes include vascular lesions
(angioplasia), small bowel tumours, coeliac disease and Crohns disease.
NICE Interventional Procedures Overview: Wireless capsule endoscopy Page 1 of 26

Crohn's disease is a chronic inflammatory disease of the intestine. It primarily causes
ulceration (breaks in the lining) of the small and large intestines, but can affect the
digestive system anywhere from the mouth to the anus. Common symptoms of
Crohn's disease include abdominal pain, diarrhoea, and weight loss.
Current diagnostic tests and alternatives
The small bowel is the most likely source of blood loss in patients with obscure
gastrointestinal bleeding. It is considered to be one of the most difficult sections of
the gastrointestinal tract to examine because of its length and complicated
configuration. There are several methods for the endoscopic evaluation of the small
intestine, including push enteroscopy (a long tube which has a small video camera
attached), intraoperative endoscopy and small bowel follow through. Push
enteroscopy is the most commonly used of these methods because it is less invasive
and has a relatively high diagnostic yield, although it is does not examine the whole
bowel. For most of these methods the diagnostic accuracy (ability to correctly
diagnose both positive and negative disease) is poor.
Crohn's disease may be suspected in patients who have had diarrhoea, abdominal
pains and weight loss for an extended period of time. Small-bowel follow through
(where the patient is required to drink barium and then have x-ray pictures taken of
their abdomen at timed intervals) is the most commonly used diagnostic procedure
and may be used to define the distribution, nature, and severity of the disease. Other
tests include stool tests, blood tests, sigmoidoscopy (investigation of the lower bowel
with a tube and light) and colonoscopy (investigation of the colon with a fibre optic
telescope).
What the procedure involves
The patient swallows a small capsule, usually after an overnight fast. This capsule
consists of a camera, a light source and a wireless circuit for the acquisition and
transmission of signals. A small battery, which can last up to 8 hours, powers the
capsule.
As the capsule moves trough the gastrointestinal tract, images are transmitted by the
digital radiofrequency communication channel to a data recorder, worn on a belt
outside the body. This data are transferred to a computer for interpretation. The
capsule is then passed in the patients stool and discarded.
This procedure allows for the end-to-end exploration of the small bowel. However if a
patient has a motility disorder or stricture this may preclude successful investigation.
Efficacy
Obscure gastrointestinal bleeding
The published evidence suggests that wireless capsule endoscopy can detect a
bleeding source in 3176% of patients with obscure gastrointestinal bleeding. In all
studies, wireless capsule endoscopy had a higher diagnostic yield (proportion of
patients identified with a lesion) than the comparator test. However, in most cases
patients had undergone extensive prior investigations, which is likely to decrease the
diagnostic yield for the comparator procedures. It is also not possible to determine
the relative diagnostic performance (ability to correctly diagnose both positive and
negative disease) of wireless capsule endoscopy compared with alternative
conventional diagnostic tests. Several studies reported that capsule endoscopy
NICE Interventional Procedures Overview: Wireless capsule endoscopy Page 2 of 26

findings had changed patient management, but limited details were given as to
whether change in management improved health outcomes.
Suspected Crohns disease
The evidence indicates that wireless capsule endoscopy identifies small bowel
lesions suggestive of Crohns disease in 4371% (9/2112/17) patients with normal
findings on conventional tests. Three studies reported that capsule endoscopy
findings had changed patient management, with two studies reporting clinical
improvement in 83100% (10/129/9) of patients.
The available evidence, however, is not of sufficient quantity and quality to determine
the relative diagnostic performance of wireless capsule endoscopy compared with
alternative conventional diagnostic tests in diagnosing unselected patients with
suspected Crohns disease.
The Specialist Advisors noted a lack of comparative data in relation to existing
technology. They also considered that the main indication for the procedure and its
place in the diagnostic work-up of patients was still to be defined.
Safety
Obscure gastrointestinal bleeding/suspected Crohns disease
No significant complications were reported in the studies. The most commonly
reported adverse events associated with the procedure were abdominal pain,
nausea, and vomiting. Delayed passage of the capsule was also reported in a
number of studies and in the majority of cases was resolved without incident. In a
study of 200 patients done to assess the complications associated with the use of
capsule endoscopy, 6 (3%) patients had complications associated with the
procedure. This included 1 patient who was unable to swallow the capsule, 1 patient
who inadvertently aspirated the capsule and 2 patients who experienced delayed
passage and had to have surgery to remove the capsule.
The Specialist Advisors considered that this was a safe procedure. They felt that the
most likely adverse event was that the capsule might become lodged in narrowed
areas of the small bowel, causing bowel obstruction. One Advisor commented that
this complication was more likely in patients with suspected Crohns disease rather
than obscure gastrointestinal bleeding.
Literature reviews
Rapid review of literature
The medical literature was searched to identify studies and reviews relevant to
wireless capsule endoscopy. Searches were conducted using the following
databases: MEDLINE, PREMEDLINE, EMBASE, Cochrane Library and Science
Citation Index, and covered the period from their commencement to February 2003.
Trial registries and the Internet were also searched. No language restriction was
applied to the searches.
The following selection criteria (Table 1) were applied to the abstracts identified by
the literature search. Where these criteria could not be determined from the abstracts
the full paper was retrieved.
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Table 1 Inclusion and exclusion criteria for identification of relevant
studies

Characteristic Criteria
Publication type Clinical studies included. Emphasis was placed on identifying good-quality published studies
that reported on the diagnostic performance of the procedure.
Abstracts were excluded where no clinical outcomes were reported, or where the paper was
a review, editorial, laboratory or animal study.
Patient Patients with obscure gastrointestinal bleeding.
Patients with suspected Crohns disease.
Intervention/test Wireless capsule endoscopy.
Outcome Studies were required to report at least one of the following: diagnostic yield, diagnostic
performance, effect on patient management, or effect on health outcomes for wireless
capsule endoscopy in relation to diagnostic alternatives. Articles were retrieved if the abstract
contained information relevant to the safety and/or efficacy.
Language Non-English-language articles were excluded unless they were thought to add substantively
to the English-language evidence base.

List of studies included in the overview
The evidence on wireless capsule endoscopy in patients with obscure
gastrointestinal bleeding is based on a systematic review (health technology
assessment)
1
and five studies published after the literature search date of the
systematic review.
2-6

The evidence on wireless capsule endoscopy in patients with suspected Crohns
disease in based on five studies.
7-11

An additional three studies were included for the purpose of addressing
complications associated with wireless capsule endoscopy.
12-14

Existing reviews of the procedure
Three health technology assessment reports were identified relevant to this topic.
Medical Services Advisory Committee Wireless capsule endoscopy for patients
with obscure digestive tract bleeding (literature search date: October 2002, March
2003).
Blue Cross Blue Shield Association Wireless capsule endoscopy for obscure
digestive tract bleeding (literature search date:July 2002).
Blue Cross Blue Shield Association Wireless capsule endoscopy for small-bowel
diseases other than obscure GI bleeding (Literature search date: November
2003).
The findings of these reports are outlined in Appendix B.
NICE Interventional Procedures Overview: Wireless capsule endoscopy Page 4 of 26

Table 2 Summary of key efficacy and safety findings for obscure gastrointestinal bleeding
Abbreviations used: CE capsule endoscopy; PE push enteroscopy; SBS small bowel series SBFT small bowel follow through
Study details Comparator Key efficacy findings Key safety findings Comments
MSAC report (2003)
1

Systematic review

Literature search date: October 2002 and
March 2003 (Medline)

Comparative studies
(n = number of patients receiving capsule)
Costamagnata et al (2002)
15
13 patients
Ell et al (2002)
16
32 patients
Florent et al (2003)
17
59 patients
Hartmann et al (2003)
18
33 patients
Lewis & Swain (2002)
19
21 patients
Selby and Desmond 2003
20
40 patients

Abstracts efficacy and safety
Gonzalez-Asanza et al (2002) 12 patients
Lim et al (2003)
21
29 patients
Mylonaki et al (2002)
22
38 patients

Abstracts efficacy only
Demedts et al (2002)
23
18 patients
Hartmann et al (2003)
24
21 patients
Intraoperative
Neu er al (2003)
25
52 patients
Nietsch et al
26
27 patients
Pennazio et al (2002)
27
45 patients
Toth et al (2003)
28
28 patients
Van Gossum et al (2002)
29
21 patients

Non-comparative studies only reviewed for
safety.









SBS
PE
PE
PE
PE
PE


PE
PE
PE


PE
PE
PE
PE
PE
PE
Diagnostic yield (percentage definite diagnosis)

CE Comparator
Study n Definite Definite
Costamagnata 13 31% 5%
Ell 32 66 % 28 %
Florent 59 56% 32%
Hartmann 33 76% 21%
Lewis & Swain 21 55 % 40%
Selby & Desmond 73 73% 28%

Gonzalez-Asanza 12 75% 56%
Lim 29 72 % 34%
Mylonaki 38 55% 33%
Demedts 18 78% 56%
Hartmann 21 81 % 81%
Neu 52 71 % 29 %
Nietsch 27 63 % 27 %
Pennazio 45 73 % 42 %
Toth 28 46 % 21 %
Van Gossum 21 62 % 76 %

Bayesian analysis results
Diagnostic Test
Capsule endoscopy Small
bowel series
Main analyses
Diagnostic yield 0.58 0.035
95% Credibility Interval 0.463-0.677 0.005-0 .120

Odds Ratio 37.3 37.3
95% Credibility Interval 9.43-270.97 9.43-270.97
Adverse events
Comparative data
(In 9 studies)
No adverse events were
reported in 7 studies

2 studies reported:
5/59 patients bleeding
abdominal pain; abdominal
pain with nausea;
abdominal pain with
nausea and vomiting
2/41 patients mild
abdominal pain; death due
to coronary occlusion.


Non-comparative data
(In 15 studies authors made
comment on adverse events)
No adverse events were
reported in 9 studies
6 studies reported:
1/1 capsule lodged in
circopharyngeus
2/35 mild abdominal pain
1/4 abdominal pain
1/259 obstructive
symptoms
1/1 capsule lodged in
bronchus
1/1 gastrointestinal

Systematic review provided
an indirect comparison,
that is, small bowel series
versus push enteroscopy.

Small bowel series was
determined to be the main
comparator.

Studies varied in their
definition of a positive
diagnosis.

Sensitivity analysis
includes abstracts and
unpublished studies.

Trials with 10 or fewer
patients were excluded
from the efficacy
evaluation. However,
adverse events and safety
outcome data from such
trials were included.





Trials were excluded where
there was inadequate
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Abbreviations used: CE capsule endoscopy; PE push enteroscopy; SBS small bowel series SBFT small bowel follow through
Study details Comparator Key efficacy findings Key safety findings Comments
Fleischer et al (2003)
30
1 patient
Gay et al (2002)
31
1 patient
Hahne et al (2002)
32
1 patient
Hartmann et al (2003) 48 patients
Hollerback er al (2003)
33
2 patients
Jonnalagadda and Prakash (2003)
34
3 patients
Mylonki et al (2002)
35
1 patient
Scapa et al (2002)
36
35 patients
Scapa et al (2002)
37
1 patient
Smith (2002)
38
19 patients

Abstracts safety only
The systematic review lists more than 60
abstracts reviewed for safety (for more detail
see Appendix C of the Systematic Review)

Incomplete studies
CEDIT (2003)

Capsule endoscopy Small
bowel series
Sensitivity analyses

Diagnostic yield 0.64 0.039
95% Credibility Interval 0.576-0 .698 0.006-0 .137

Odds Ratio 42.9 42.9
95% Credibility Interval 10.98-317.35 10.98-317.35

Change in management and health outcomes
Limited information
obstruction

Delayed passage
20 studies reported cases of
delayed passage of the
capsule endoscopy
separation of results on the
basis of the patient
population.
Pennazio et al (2004)
2


100 consecutive patients
January 2001 March 2002
26 patients with ongoing obscure-overt
bleeding
31 patients with previous obscure-overt
bleeding
43 patients with obscure occult bleeding

Push enteroscopy (PE) was performed in 51
patients shortly before or after capsule imaging.

Mean age: 63 years (range 1888 years)
PE
(before and after
capsule)
Outcomes reported: diagnostic yield, diagnostic accuracy,
therapeutic management

Capsule n = 100
Positive findings in 47 patients (47%; 95% CI 3757%)
Suspicious in 15 patients (15%; 95% CI 821%)
Negative in 38 patients (38%; 95% CI 2847%)
Diagnostic yield n = 100
ongoing obscure-overt bleeding (92.3%; 95% CI 82100%)
previous obscure-overt bleeding (12.9%; 95% CI 1.225%)
obscure occult bleeding (44.1%; 95% CI 2959%)

Capsule endoscopy found the source of bleeding in 18/36 patients
with a negative push enteroscopy.
Complications:
5 (5%) patients had non-
natural excretion of the
capsule
Looks as though published
results of
27


Diagnostic yield: defined as
the frequency of detection
of clinically relevant lesion.

Sensitivity and specificity
defined as:
True positive verification
of capsule endoscopy by
surgery, endoscopy or
other alternative means
(such as angiography).
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Abbreviations used: CE capsule endoscopy; PE push enteroscopy; SBS small bowel series SBFT small bowel follow through
Study details Comparator Key efficacy findings Key safety findings Comments

Median length of bleeding: 1 195 months

Patients had undergone a total of 620
diagnostic tests.

Mean follow up: 18 months (range 525 moths)

Follow up available on
23 patients with ongoing obscure-overt
bleeding
29 patients with previous obscure-overt
bleeding
39 patients with obscure occult bleeding

Follow up data not available for 9 patients


Push enteroscopy n = 51
Identified bleeding source in 15 patients (29% 95% CI 2336%) 3
were not detected by capsule endoscopy

Combined findings
Diagnostic yield for the two techniques was 67% (33/51 patients)
95% CI: 5480%.

Lesions were identified by both techniques in 12 patients
by capsule endoscopy only in 18 patients
by push enteroscopy only in 3 patients

Diagnostic accuracy
62 patients underwent further investigations with a final diagnosis
in 56 patients.
36 had positive diagnosis
20 had negative diagnosis
Capsule positive 32/36 patients (sensitivity of 88.9%)
Capsule negative in 19/20 patients (specificity 95%)
Positive predictive value was 97%
Negative predictive value was 82.6%
Overall accuracy was 91.1%
False positives were in patients with previous obscure and occult
bleeding

Therapeutic management
Capsule findings lead to changes in 86.9% of patients with ongoing
obscure-overt bleeding and 69.2% and 41.4% of patients with
previous obscure-overt bleeding or obscure occult bleeding
respectively


True negative negative
capsule study and bleeding
resolved with no further
treatment.

False positive positive
capsule study with a
different lesion found on
subsequent workup.
False negative negative
capsule study with lesion
diagnosed by other means.

Cant really compare
findings of capsule with PE
because of timing.

Greater proportion of
patients with ongoing
obscure bleeding
underwent further
investigations.

Diagnostic accuracy based
on only a small number of
patients.

Independent verification
not available for all
patients.

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Abbreviations used: CE capsule endoscopy; PE push enteroscopy; SBS small bowel series SBFT small bowel follow through
Study details Comparator Key efficacy findings Key safety findings Comments
Saurin et al (2003)
3


60 patients
32 patients with occult obscure bleeding
28 patients with overt obscure bleeding

All patients had obscure digestive bleeding

To be included patients had to have undergone
at least one complete set of endoscopic
examinations of the digestive tract the results of
which were negative

Mean age: 58 years (range 2179 years)

Mean duration of symptoms: 24.8 months.

Follow up: not stated

PE
(performed
within 3 days)
Outcomes reported: diagnostic yield

Lesions were classified into three categories
P2 high potential for bleeding
P1 uncertain hemorrhagic potential
P0 no potential for bleeding

15 patients had normal findings from capsule and push
enteroscopy

Diagnosis CE+/ CE+/ CE -/ Total
PE+ PE- PE+
Anglomata 11 6 2 19
Mucosal red spots 2 10 1 13
Ulcerations 3 3 - 6
Erosions 1 1 - 2
Tumours 1 1 - 2
Intestinal varices 1 - - 1
Total 19 21 3 43

Diagnostic yield
The additional diagnostic value of capsule enteroscopy was 36.2%
(21/58) when looking at PI and P2 lesions and 17.2% (10/58) when
just looking at P2 lesions. Increase in diagnostic yield was
statistically significant p = 0.0396.

Diagnostic yield capsule = 40/58 (69.0%)
Diagnostic yield enteroscopy = 22/58 (37.9%)





Complications:
Authors stated that no
complication was observed
during the study with either
type of enteroscopy
Looks as though published
results of
17

Patients were described as
consecutive.

Push enteroscopy carried
out by an independent
operator blinded to results.

2 patients capsule
enteroscopy recordings
could not be analysed.

Lesions classified as PO
and those outside the small
intestine are not taken into
account.

Concordance between
observers appeared to be
good in patients with
obvious bleeding and in
negative studies however
in patients with less
clinically relevant lesions
the concordance
decreased.
NICE Interventional Procedures Overview: Wireless capsule endoscopy Page 8 of 26

Abbreviations used: CE capsule endoscopy; PE push enteroscopy; SBS small bowel series SBFT small bowel follow through
Study details Comparator Key efficacy findings Key safety findings Comments
Mylonaki et al (2003)
4


UK

52 patients (50 patients evaluable)
11 patients with overt bleeding
39 patients with occult bleeding

In two patients data could not be analysed
these patients are not included in the analysis.

To be included patients had to have a
gastroscopy and colonoscopy which was
negative.

Number of investigations: 8 (317)

Median age: 50.3 years (range 1780 years)

Median duration of bleeding: 4.2 years (0.520
years)

Follow up: 2 weeks


PE
(two weeks after
capsule
endoscopy)
Outcomes reported: diagnostic yield, therapeutic impact and
patient satisfaction.

Diagnostic yield
Capsule: Identified a bleeding source in the small intestine in 34/50
patients (68%).
Including diagnosis outside the small intestine 38/50 patients
(76%)
All gastric abnormalities were confirmed at subsequent push
enteroscopy; the colonic abnormalities were confirmed and treated
at subsequent colonoscopy

Push enteroscopy: Identified a bleeding sources in the small bowel
in 16/50 patients (32%)
Following a second enteroscopy another source and including
additional extraintestinal diagnoses diagnostic yield was 19/50
(38%)

Wireless capsule endoscopy was significantly superior to push
enteroscopy in the identification of bleeding sources p < 0.05 (both
taking into account small intestine results and all results)

Therapeutic impact: (denominator those with positive findings)
Authors note that wireless capsule endoscopy led to alteration in
therapy in 25/38 patients. Seven patients had surgery

Satisfaction
49/50 patients said they found the capsule preferable to push
enteroscopy
2/50 found the capsule to be uncomfortable but only at the
time of swallowing
34/50 found push enteroscopy to be painful

Complications:
1 patient delayed passage

Other technical problems such
as battery power expiring.
Results were reviewed by
independent and blinded
endoscopist.

Not reported how patients
had positive CE findings
and positive PE findings.

Unclear what a successful
result means.

In 2/38 patients there was
disagreement on
interpretation as to the
source of the bleeding.

Fourteen volunteers were
also examined to acquire
information n the normal
appearance of the small
bowel.
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Abbreviations used: CE capsule endoscopy; PE push enteroscopy; SBS small bowel series SBFT small bowel follow through
Study details Comparator Key efficacy findings Key safety findings Comments
Buchman et al (2003)
5

USA

20 patients with obscure bleeding
9 men mean age: 54.8 years
11 women mean age: 65.6 years

Patients had been hospitalised on at least 1
occasion for gastrointestinal bleeding

All had at least 1 negative
esophogastroduodenoscopy (EDG), 1 negative
colonoscopy and 1 negative small bowel barium
contrast study

Follow up: 1 week (unclear)

PE (1 week after
capsule)
Outcomes reported: diagnostic yield, therapeutic impact

Diagnostic yield
Capsule: 12/20 (60%) patients had bleeding source successfully
identified
Normal findings were present in 7/20 patients and 1 patient had a
poor prep

Push enteroscopy: 7 patients refused enteroscopy. 4/7 patients
that refused enteroscopy had normal capsule results
2/13 (15%) patients had bleeding source successfully identified by
push enteroscopy

Capsule found a bleeding source in 9/13 patients (p = 0.02)
(unclear if this includes 2 patients identified by push enteroscopy)

Therapeutic impact
Capsule lead to successful surgical resection in 3 patients

Complications
Capsule passed naturally by
all subjects
Authors note patients were
consecutive.

Results read by an
independent and blinded
endoscopist.

Unclear what is means by
successful in determining
a bleeding source.

Authors also note that they
have examined an
additional 16 patients using
capsule endoscopy.

Refusals in the push
enteroscopy group means
that results are based on
small numbers.
Hara et al (2004)
6

USA

Retrospective study

September 2001 April 2002

52 patients (42 met the inclusion criteria unclear
which patients)
43 patients obscure gastrointestinal
bleeding
8 patients inflammatory bowel disease
Small bowel
radiography (40
examinations)

CT
(19
examinations)

Patients had to
have undergone
tests within
6 months of
capsule
Outcomes reported: diagnostic yield, therapeutic impact

Diagnostic yield: capsule versus small bowel
Capsule: 19/40 (47.5%) patients had bleeding source identified
Negative findings were present in 21/40 patients

Small bowel examination: 1/40 (2.5%) patients had bleeding
source identified
Negative findings were present in 39/40 patients

Diagnostic yield: capsule versus CT

Capsule: 12/19 (63%) patients had bleeding source identified
Demographic data
presented on the 52
patients not the 42
patients.

When available, image
tests and capsule
endoscopy results were
also compared with
endoscopy, surgical and
biopsy results.

Results were not reviewed
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Abbreviations used: CE capsule endoscopy; PE push enteroscopy; SBS small bowel series SBFT small bowel follow through
Study details Comparator Key efficacy findings Key safety findings Comments
1 patient with chronic abdominal pain

33 patients were from one study institution
9 patients were from other institutions
31 patiens were men, mean age 64 years
21 were women, mean age 63 years

Patients without a history of small bowel
stricture or with a barium study negative for a
stricture underwent capsule endoscopy

endoscopy

Negative findings were present in 7/19 patients

CT: 4/19 (21%) patients had bleeding source identified
Normal findings were present in 15/19

Surgical results available on some patients. Difficult to ascertain
false positives and false negatives

blinded.

6 examinations were
performed more than
3 months from capsule
endoscopy.

Heterogeneous group of
patients.

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Table 3 Summary of key efficacy and safety findings for patients with suspected Crohns disease

Abbreviations used: CE capsule endoscopy; PE push enteroscopy; SBFT small bowel follow through; SBS small bowel series
Study details Comparator Key efficacy findings Key safety findings Comments
Eliakim (2003)
7


20 consecutive patients

Patients had recurrent abdominal pain
and/or chronic diarrhoea with or
without weight loss

Mean age was 30.8 years (20
57 years)

Mean duration of symptoms:
8 months

Follow up: not stated

Barium follow-
through

Entero-CT
Outcomes reported: diagnostic yield.

Diagnostic yield
Capsule: findings were medically significant
14/20 patients Diagnostic yield = 70%

Comparative procedures (barium/CT)
Found abnormalities in 10/20 patients, and medically
significant in 7/20 patients. Diagnostic yield = 35%

Colonsoscopy and ileoscopy with biopsy confirmed the
capsules findings in 8 patients in which there were
controversial results between procedures
Complications
Authors report no side
effects during or after the
procedure
Blinded interpretation.

All three procedures were completed
within 3 months.

Noted that colonoscopy and ileoscopy
was undertaken in most cases in
which there was a discrepancy
between tests.

Patients had gone through 48
procedures before entry to this study.

Unclear how many patients had
controversial results.
Fireman (2003)
8


17 patients suspected Crohns
disease (originally 18; 1 patient was
excluded)

August 2000December 2001

All patients had clinical symptoms

Mean age: 40 (range 1868 years)
Mean duration of symptoms:
6.3 years
Follow up: 4 months (18 months)
None Outcomes reported: diagnostic yield, therapeutic management

Diagnostic yield: 12/17 patients (70.6%) were diagnosed with
suspected Crohns disease
5/17 patients were assessed as having normal looking bowel

Therapeutic management: 12 patients received medication for
Crohns disease. 10/12 patients showed good clinical
improvement
Complications
All capsules were passed
without intervention
Six months prior to entry all patients
had undergone conventional
investigations all revealing a normal
bowel. (15/17 total colonoscopy; 16/17
oesophageal gastroduodenoscopy;
7/17 abdominal CT scans.)

Not stated as consecutive.

Two independent examiners blinded to
clinical data.
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Abbreviations used: CE capsule endoscopy; PE push enteroscopy; SBFT small bowel follow through; SBS small bowel series
Study details Comparator Key efficacy findings Key safety findings Comments
Harrerias et al (2003)
9


21 patients

Patients presented with symptoms of
Crohns disease

Mean age: 43 years

Duration of symptoms: more than
6 months

Follow up: unclear 3 months?

None Outcomes reported: diagnostic yield

Diagnostic yield: 9/21 patients (43%) had medically
significant findings

Therapeutic management: 9 patients received medication
following diagnosis. All of the patients are in clinical remission
at time of writing
Complications
Authors note that there
were no adverse effects
caused by the technique
Conventional and radiological
techniques had not identified
pathological findings.
Chong (2003)
10


9 patients 7 patients known/ 2
suspected Crohns disease (from a
population of 60 consecutive patients)

4 July 2001 8 September 2002

Patients were required to have a
small bowel barium study to exclude
strictures

Follow up: not stated

None Outcomes reported: diagnostic yield, therapeutic management

Diagnostic yield: 7/9 patients (78%) had findings that were
medically significant

2 patients (1 with known and 1 with suspected Crohns) had
normal findings

Therapeutic management : 5/9 patients had change of
management
2 patients were lost to follow up; 2 patients had no change
(including one patient with known Crohns who had normal
capsule findings)







Complications
1/60 patients had retention
of the capsule
No comparator.

Suspicion of Crohns disease was
based on a combination of clinical
features.

Capsule findings were reviewed by two
gastroenterologists.

Positive findings detected
abdominalities that were potentially
related to the presenting problem.

Limited information.
NICE Interventional Procedures Overview: Wireless capsule endoscopy Page 13 of 26

Abbreviations used: CE capsule endoscopy; PE push enteroscopy; SBFT small bowel follow through; SBS small bowel series
Study details Comparator Key efficacy findings Key safety findings Comments
Bloom et al (2003)
11


16 patients known or suspected
Crohns disease without stricture

Small bowel
follow through

Ileoscopy

(performed
within a
6 week period
prior to
capsule)
Outcomes: diagnostic yield

Diagnostic yield: 9/16 (56%) had small bowel findings
diagnostic of Crohns disease
Proximal small bowel lesions seen in 7/16 (44%)

3/16 (19%) had SBFT findings diagnostic of Crohns disease
7/16 (44%) has ileoscopy findings diagnostic of Crohns disease
No proximal lesions were identified by SBFT or ileoscopy
Complications
Authors report no
complications occurred.
Abstract.

Limited information.

NICE Interventional Procedures Overview: Wireless capsule endoscopy Page 14 of 26


Table 4 Additional safety data for wireless capsule endoscopy

Abbreviations used: CE capsule endoscopy; PE push enteroscopy; SBS small bowel series; SBFT small bowel follow through
Study details Comparator Key efficacy
findings
Key safety findings Comments
Hutchinson et al (2003)
12


200 patients
112 male, 88 female
Indications included:
anemia 171 patients
evaluation of inflammatory bowel disease 16 patients
evaluation of malabsorption 13 patients

Mean age 52 years (range 1873 years)

None None Complications
6 patients (3%) had complications associated with the procedure
1 patient was unable to swallow the capsule
2 patients had battery failure
1 patient aspirated the capsule into the trachea
2 patients with bowel obstruction (one patient had
strictures) both patients underwent laporotomy for
removal

Abstract.

Limited information.
Barkin et al (2002)
13


937 patients

Patients are those included in capsule studies at different
centres


None None Complications
7 patients (0.75%) required intervention for capsule removal
6 patients for obstruction/stricture
1 patient for bleeding ulcer

All patients had resolution of their symptoms

Non-natural passage revealed unsuspected pathology in 7
patients, which had not be revealed by other studies including
small bowel
Abstract.

Limited information.

Only reports on the incidence and
clinical features of those patients in
whom the capsule become lodged in
the small bowel and required
removal it does not report on
delayed passage.
NICE Interventional Procedures Overview: Wireless capsule endoscopy Page 15 of 26

Abbreviations used: CE capsule endoscopy; PE push enteroscopy; SBS small bowel series; SBFT small bowel follow through
Study details Comparator Key efficacy
findings
Key safety findings Comments
Smith et al (2002 )
14


October 2001June 2002
71 patients (75 examinations): 33 women, 38 men

Mean age was 63 years (range 2787 years)

Indications included:
Obscure GI bleeding 64 patients
abdominal pain 6 patients
suspected small bowel tumour in 1 patient
None None Complications
3 capsule failures requiring repeat examination
1 capsule had not passed beyond the pylorus
1 capsule was retained
5 examinations were compromised by transmission gaps
The colon could not be reached in 12/67 patients (18%)
and passage of the IC valve could not be assessed in an
additional 3 patients
1 patients experienced capsule retention (surgery needed)
1 patient delayed passage for 2 weeks (surgery needed)
Abstract.

Limited information.

All patients underwent EGD,
colonscopy, and SBFT prior to CE.


NICE Interventional Procedures Overview: Wireless capsule endoscopy Page 16 of 26

Validity and generalisability of the studies
Only one study reported on the diagnostic performance (sensitivity and
specificity) of the procedure. Sensitivity and specificity were calculated using
author defined definitions. Although a combination of tests (including push
enteroscopy, which some patients had already undergone) was used to
independently verify results, this was not done using an accepted methodology
such as the discrepant resolution method or a composite reference standard
approach
39
. As such, sensitivity and specificity may be misleading and may not
accurately reflect diagnostic performance of the procedure.
In the majority of studies diagnostic yield (number of patients identified with a
lesion/total number of patients assessed) was considered the most appropriate
measure of diagnostic test performance.
However, diagnostic yield cannot differentiate true positives from false positives
or true negatives from false negatives.
In most of the studies blinded independent assessment was undertaken in
reviewing the test results.
In all of the published studies patients had undergone extensive prior
investigations, often including investigation with the comparator procedure in
some cases patients were those that had normal readings on other tests. This is
therefore likely to decrease the apparent diagnostic yield for the comparator
procedures.
The timing of these comparator tests varied (from within 3 days of having a
capsule endoscopy to 6 months). The longer the time between the two tests, the
more likely that diagnostic yield will be over or under estimated.
Studies had different definitions as to what constitutes a positive diagnosis,
therefore limiting the comparisons that can be drawn among the studies in terms
of diagnostic yield.
Different studies also used different comparators again limiting the comparisons
that can be made.
In general, the patients included in the studies are a heterogeneous group
2
. In
some studies
6,15
patients other than those with obscure gastrointestinal bleeding
were included in the study population. It is unclear what impact this has on overall
diagnostic yield, particularly given there is some suggestion that there are
particular patient groups who are the better candidates for this procedure
2
.
Follow up in most of the studies was short or in some cases unclear. This limits
the ability to draw conclusions regarding the therapeutic impact of the test or the
impact on health outcomes.
Specialist Advisors opinions
Specialist advice was sought from consultants who have been nominated or ratified
by their Specialist Society or Royal College.

The main utility of capsule endoscopy will be in the diagnosis of obscure
gastrointestinal bleeding however these patients present relatively infrequently.
There are potential expansions for the role of the capsule in terms of screening
and in the evaluation of inflammatory bowel disease, but these are by no means
established at this point.
Clinical follow up will be necessary to confirm value of findings.
The experience in relation to the endoscopic capsule is that it performs at least as
well as barium follow through and enteroscopy, but that these procedures are
complementary and should not be regarded as competitors.
NICE Interventional Procedures Overview: Wireless capsule endoscopy Page 17 of 26

There is a substantial interest worldwide in capsule endoscopy.
Issues for consideration by IPAC
The place of this procedure in the management of patients with obscure
gastrointestinal bleeding and suspected Crohns disease is still unclear i.e will it be
used incrementally/triage or as a replacement test.
There appears to be a significant interest in the use of this procedure - further
studies on this procedure are continually being published.
References
1. Medical Services Advisory Committee. M2A Capsule endoscopy: for the
evaluation of obscure gastrointestinal bleeding in adult patients. 1057. 2003.
Ref Type: Report
2. Pennazio M, Santucci R, Rondonotti E, Abbiati C, et al. Outcome of patients
with obscure gastrointestinal bleeding after capsule endoscopy: Report of 100
consecutive cases. Gastroenterology 2004;126(3):643-53.
3. Saurin J-C, Delvaux M, Gaudin J-L, Fassler I, et al. Diagnostic value of
endoscopic capsule in patients with obscure digestive bleeding: Blinded
comparison with video push-enteroscopy. Endoscopy 2003; 35(7):01.
4. Mylonaki M, Fritscher-Ravens A, Swain P. Wireless capsule endoscopy: a
comparison with push enteroscopy in patients with gastroscopy and
colonoscopy negative gastrointestinal bleeding. Gut 2003; 52(8):11226.
5. Buchman AL, Wallin A. Videocapsule endoscopy renders obscure
gastrointestinal bleeding no longer obscure. Journal of Clinical
Gastroenterology 2003; 37(4) 303-06
6. Hara AK, Leighton J, Sharma VK, Fleischer DE. Small bowel: preliminary
comparison of capsule endoscopy with barium study and CT. Rays 2004;
230:2605.
7. Eliakim R, Fischer D, Suissa A, Yassin K, et al. Wireless capsule video
endoscopy is a superior diagnostic tool in comparison to barium follow-
through and computerized tomography in patients with suspected Crohns
disease. European Journal of Gastroenterology & Hepatology 2003;
15(4):3637.
8. Fireman Z, Mahajna E, Broide E, Shapiro M, et al. Diagnosing small bowel
Crohns disease with wireless capsule endoscopy. Gut 2003; 52(3):3902.
9. HerrerA-as JMC. Capsule endoscopy in patients with suspected Crohns
disease and negative endoscopy. Endoscopy 2003; 35(7):5648.
10. Chong AK, Taylor AC, Miller AM, Desmond PV. Initial experience with
capsule endoscopy at a major referral hospital. Medical Journal of Australia
2003; 178(11):53740.
NICE Interventional Procedures Overview: Wireless capsule endoscopy Page 18 of 26

11. Bloom PD, Rosenberg MD, Klein SD. Wireless capsule endoscopy (CE) is
more informative than ileoscopy and SBFT for the evaluation of the small
intesting (SI) in patients with known or suspected Crohns disease.
Gastroenterology 2003 124[1], Suppl 1 A. Abstract.
12. Hutchinson DS, Barawi M, Bermudez F, Taggart T, Ravi V. A prospective
study assessing the complications associated with the use of wireless-
capsule endoscopy (WCE). American Journal of Gastroenterology 2003 98
[9 Suppl], S290. Abstract.
13. Barkin JS, Friedman S. Wireless Capsule Endoscopy requiring surgical
intervention: the worlds experience. The American Journal of
Gastroenterology 2002; 97(9, Supplement 1):S298.
14. Smith MA, Mergener K, Schembre DB, Brandabur JJ, et al. Complications
and problems with capsule endoscopy. The American Journal of
Gastroenterology 2002; 97(9, Supplement 1):S301.
15. Costamagna G, Shah SK, Riccioni ME, Foschia F, et al. A prospective trial
comparing small bowel radiographs and video capsule endoscopy for
suspected small bowel disease. Gastroenterology 2002; 123(4):9991005.
16. Ell C, Remke S, May A, Helou L, et al. The first prospective controlled trial
comparing wireless capsule endoscopy with push enteroscopy in chronic
gastrointestinal bleeding. Endoscopy 2002; 34(9):6859.
17. Florent C, Gay G, Ponchon T. Evaluation of the Given Video Capsule System
in the diagnosis of chronic anemia of digestive origina secondary to obscure,
actif and/or occult bleeding. 2003. Unpublished work
18. Hartmann D, Schilling D, Bolz G, Hahne M, et al. Capsule endoscopy versus
push enteroscopy in patients with occult gastrointestinal bleeding. Zeitschrift
fur Gastroenterologie 2003; 41(5):01.
19. Lewis BS, Swain P. Capsule endoscopy in the evaluation of patients with
suspected small intestinal bleeding: Results of a pilot study. Gastrointestinal
Endoscopy 2002; 56(3):349353.
20. Selby W, Desmond PV. Performance evaluation of the Given Diagnostic
Imaging System in the diagnosis of obscure GI bleeding, and Performance
evaluation of the Given Diagnostic Imaging System in chronic gastrointestinal
bleeding. 2003. Unpublished work.
21. Lim RM, OLoughlin CJ, Barkin S. Comparison of wireless capsule endoscopy
(M2AI) with push enteroscopy in the evaluation of obscure gastrointestinal
bleeding. The American Journal of Gastroenterology 2002; 97(9, Supplement
1):S83.
22. Mylonaki M, Fritscher-Ravens A, Swain CP. Clinical results of wireless
capsule endoscopy. Gastrointestinal Endoscopy 55[5], AB146. 2002.
Abstract.
23. Demedts I, Gevers A, Hiele M, Tack J, et al. A prospective comparative study
of capsule vs push enteroscopy in obscure gastrointestinal bleeding. 10
th

United European Gastroenterology Week Geneva. 2002. Abstract..
NICE Interventional Procedures Overview: Wireless capsule endoscopy Page 19 of 26

24. Hartmann D, Schmidt H, Schilling D, Bolz G, et al. Prospective controlled
multicentre trial comparing wireless capsule endoscopy with intraoperative
enteroscopy in patients with chronic gastrointestinal bleeding: preliminary
results. Digestive Disease Week, Orlando Florida. 2003. Abstract.
25. Neu B, Schmid E, Ell C, Riemann JF, et al. GECCO-German Cooperative
Capsule Outcome Study 2: Capsule Endoscopy compared to other
nteroscop tests in small bowel bleeding. Digestive Disease Week, Orlando
Florida 2003. Abstract.
26. Nietsch H, Saunders M, Lee S, Tung B, et al. A randomised crossover trial of
capsule endoscopy and nteroscopy for obscure GI bleeding. 2
nd
Conference
on Capsule Endoscopy, Chaning Clinical Practice, Berlin. 2003. Abstract.
27. Pennazio M, Santucci R, Rondonotti E, Abbiati C, et al. Wireless capsule
endoscopy in patients with obscure gastrointestinal bleeding: Preliminary
results of the Italian multicentre experience. Digestive and Liver Disease
2001; 33(Supplement 1):A2.
28. Toth E, Fork FT, Almqvist P. Capsule enteroscopy in obscure gastrointestinal
bleeding: a prospective comparative study. 2
nd
Conference on Capsule
Endoscopy, Chaning Clinical Practice, Berlin. 2003. Abstract.
29. Van Gossum A, Francois E, Hittelet A, Schmit A, et al. A prospective,
comparative study between push enteroscopy and wireless video capsule in
patients with obscure digestive bleeding.[comment]. Gastroenterology 2003;
125(1):276.
30. Fleischer DE, Heigh RI, Nguyen CC, Leighton JA, et al. Videocapsule
impaction at the cricopharyngenus: a first report of this complications and its
successful resolution. Gastrointestinal Endoscopy 2003; 57:4278.
31. Gay G, Delvaux M, Fassler I, Laurent V, et al. Localization of colonic origin of
obscure bleeding with the capsule endoscope: a case report. Gastrointestinal
Endoscopy 2002; 56(5):75862.
32. Hahne M, Adamek HE, Schilling D, Riemann JF. Wireless capsule endoscopy
in a patient with obscure occult bleeding. Endoscopy 2002; 34(7):58890.
33. Hollerbach S, Kraus K, Willert J, Schulmann K, et al. Endoscopically assisted
video capsule endoscopy of the small bowel in patients with functional gastric
outlet obstruction. Endoscopy 2003; 35(3):2269.
34. Jonnalagadda S, Prakash C. Intestinal strictures can impede wireless capsule
enteroscopy. Gastrointestinal Endoscopy 2003; 57(3):41820.
35. Mylonaki M, MacLean D, Fritscher-Ravens A, Swain P. Wireless capsule
endoscopic detection of Meckels diverticulum after nondiagnostic surgery.
Endoscopy 2002; 34(12):101820.
36. Scapa E, Jacob H, Lewkowicz S, Migdal M, et al. Initial experience of
wireless-capsule endoscopy for evaluating occult gastrointestinal bleeding
and suspected small bowel pathology. The American Journal of
Gastroenterology 2002; 97(11):27769.
NICE Interventional Procedures Overview: Wireless capsule endoscopy Page 20 of 26

37. Scapa E, Herbert M, Fireman Z. First histologic confirmation of the diagnosis
made by the new wireless-capsule endoscopy. Surgical Laparoscopy,
Endoscopy & Percutaneous Techniques 2002; 12(5):3646.
38. Smith J. The preliminary capsule endoscopy experience at Ochsner Clinic
Foundation. Ochsner Journal 2002; 4(4) Abstract
39. Alonzo TA, Pepe MS. Using a combination of reference tests to assess the
accuracy of a new diagnostic test. Statistics in Medicine 1999;; 18(22):2987
3003.
NICE Interventional Procedures Overview: Wireless capsule endoscopy Page 21 of 26


Appendix A: Additional studies not included in the summary
tables
This is not an exhaustive list. As mentioned above the body of evidence is rapidly
increasing in relation to this procedure it should also be noted that given that
Digestive Disease Week 2004 is in May a number of presentations on this procedure
would be expected to be published.

Article Patients/
follow up
Comments Direction of the
conclusions
Ang T-L, Fock K-M, Ng T-M, Teo E-K, et al. Clinical
utility, safety and tolerability of capsule endoscopy
in urban Southeast Asian population. World Journal
of Gastroenterology 2003; . 9(10). 23136
16 patients with
suspected small
bowel pathology
Heterogeneous
population

No comparator
Capsule
endoscopy is a
useful tool
Ge ZZ, Hu YB, Gao YJ, Xiao SD. Clinical
application of wireless capsule endoscopy. Chinese
Journal of Digestive Diseases 2003; 4(2). 8992
15 patients with
suspected
bowel disease
Heterogeneous
population

No comparator
Capsule
endoscopy is a
useful tool
particularly in
patients with
obscure bleeding
Ciorba M, Prakash C, Jonnalagadda S, Stone C, et
al. Diagnostic yield of capsule endoscopy is similar
in obscure-occult and obscure-overt gastrointestinal
bleeding but diagnoses vary. The American Journal
of Gastroenterology 2002; 97(9, Supplement
1):S80.
45 patients with
obscure
bleeding
No comparator

Abstract
Capsule
endoscopy has a
high diagnostic
yield
Mele C, Infantolino A, Conn M, Kowalski T, et al.
The diagnostic yield of wireless capsule endoscopy
in patients with unexplained abdominal pain. The
American Journal of Gastroenterology 2003; 98(9,
Supplement 1):S298.
20 patients with
unexplained
pain
Heterogeneous
population

No comparator

Abstract
Capsule
endoscopy is a
useful tool
Gross SA, Schmelikin IJ, Kwak GS. Capsule
endoscopy in a private community practice: results
of the first 178 patients. The American Journal of
Gastroenterology 2003; 98(9, Supplement 1):S291.
178 patients
with
gastrointestinal
complaints
Heterogeneous
population

No comparator

Abstract
Capsule
endoscopy is a
useful tool
Riccioni ME, Foschia F, Shah SK, Mutignani M, et
al. Diagnostic potential of the given M2A wireless
video capsule endoscopy for obscure
gastrointestinal (GI) bleeding. Digestive and Liver
Disease 2001; 33(Supplement 1):A11.
13 patients
obscure
bleeding
No comparator

Abstract
Capsule
endoscopy is a
useful tool
Mata AL. [Role of capsule endoscopy in patients
with obscure digestive bleeding]. Gastroenterologia
y Hepatologia 2003; 26(10):619-623. 619-23
21 patients
obscure
bleeding
Push enteroscopy

Non-English
Higher diagnostic
yield for capsule
endoscopy
Leighton J, Sharma V, Malikowski M, Fleischer D.
Long term clinical outcomes of capsule endoscopy
(CE) in patients with obscure gastrointestinal
bleeding (OGIB). The American Journal of
Gastroenterology 2003; 98(9, Supplement 1):S300.
20 patients
obscure
bleeding
12 months
No comparator

Abstract

Lack of detail makes
it difficult to
Procedure
improves long
term outcomes
NICE Interventional Procedures Overview: Wireless capsule endoscopy Page 22 of 26

Article Patients/
follow up
Comments Direction of the
conclusions
determine outcomes
Mitchell SH, Schaefer DC, Komar MJ, Inverso NA,
et al. Early findings of a new capsule endoscopy
program. The American Journal of
Gastroenterology 2002; 97(9, Supplement 1):S82.
16 patients Abstract

Unclear on patient
population
Capsule
endoscopy is a
useful tool
Chutkan RK, Nader BH, Tonya AL, Marsha J.
Video capsule endoscopy in the evaluation of
obscure gastrointestinal bleeding. The American
Journal of Gastroenterology 2002; 97(9,
Supplement 1):S82.
70 patients with
obscure
bleeding
Abstract High diagnostic
yield
Marmo R. A prospective trial comparing small
bowel radiographs and video capsule endoscopy
for suspected small bowel disease. Giornale
Italiano di Endoscopia Digestiva 2003; . 26(3). 207
10
20 patients Non-English Unclear
Liangpunsakul S, Chadalawada V, Maglinte D,
Lappas J, et al. Wireless capsule endoscopy
detects small bowel ulcers in patients with state of
the art normal enteroclysis. The American Journal
of Gastroenterology 2003; 98 6, 12958
40 patients No comparator

Limited information
Reports on the
detection of small
bowel ulcers
Raju GS, Abraham B, Shcreiber MH, Gomez G, et
al. A prospective comparison of enteroclysis and
capsule endoscopy in the diagnosis of obscure
gastrointestinal bleeding. The American Journal of
Gastroenterology 2003; 98(9, Supplement 1):S73.
20 patients Enteroclysis

Abstract

Capsule
endoscopy is
useful in the
evaluation of
patients with
obscure bleeding
Voderholzer WA, Ortner M, Rogalla P, Beinholzl J,
et al. Diagnostic yield of wireless capsule
enteroscopy in comparison with computed
tomography enteroclysis. Endoscopy 2003; .
35(12).100913
22 patients with
suspected small
bowel pathology
Heterogeneous
population

CT enteroclysis
Capsule
endoscopy
detects more
small bowel
lesions
Rossi S, Banwait KS, DiLisi J, Infantalino A, et al.
Diagnostic Yield of M2A capsule endoscopy
compared with sonde and push enteroscopy in
patients with obscure gastrointestinal bleeding. The
American Journal of Gastroenterology 2003; 98(9,
Supplement 1):S294.
101 patients Push enteroscopy

Abstract

Different population
for capsule and
comparator
procedures
No difference in
diagnostic yield
maybe an
indicator of
different
populations

NICE Interventional Procedures Overview: Wireless capsule endoscopy Page 23 of 26


Appendix B: Existing reviews on the wireless capsule
endoscopy
HTA Review: Medical Services Advisory Committee Wireless capsule endoscopy for patients with obscure
digestive tract bleeding
Literature search date: October 2002 and March 2003 (Medline)
Safety
Adverse events
The adverse events associated with the use of the capsule endoscopy in patients with obscure gastrointestinal
(GI) bleeding appear to be infrequent and mild in nature. The most commonly reported adverse events associated
with capsule endoscopy are abdominal pain, nausea, and vomiting.
Delayed passage of the capsule has also been associated with abdominal pain and hospitalisation in a single
patient. In another patient the retention of the capsule was associated with GI obstructive symptoms. In other
isolated cases the capsule become lodged in a patients bronchus and in a patients throat. In both of these cases
the capsule was removed without complication.
Delayed passage
In general, reported on the passage of the capsule in the available literature was poor. Delayed passage or
lodgement of the capsule was reported in less than five per cent (27/581) of all patients included in studies
systematically reported capsule passage data. Delayed passage or lodgement of the capsule was asymptomatic
in all but one of these cases. In 37 per cent (10/27) of these events the capsule had to be surgically removed from
the patient. In the majority of these cases (6/10) the capsule was removed at the time of planned surgical
management. In practice, the delay of the capsule through the GI tract often aids the clinician in the diagnosis of
previously undetected strictures.
Effectiveness
Due to the lack of a suitable reference standard for capsule endoscopy, diagnostic yield (the number of patients
with a pathological lesion identified/the total number of patients assessed) was used as the measure of diagnostic
test performance. This measure are likely to overestimate the diagnostic capabilities of both the comparator and
the procedure.
At present due to the lack of a valid reference standard only level 3 and 4 evidence is available to describe the
effectives of capsule endoscopy. 16 studies met the criteria for inclusion in the effectiveness review of capsule
endoscopy. Only one small (13 patients ) head-to-head trial comparing capsule endoscopy to small bowel series
radiology (SBS) was identified at the time of assessment. Therefore a meta-analysis incorporating evidence from
the head-to-head study of capsule endoscopy versus SBS, as well as indirect evidence from studies comparing
capsule endoscopy to push enteroscopy and PE to SBS was undertaken.
The summary point estimates of diagnostic yield for the two tests determined in the main analysis were: 58 per
cent (CI 46.3-67.7%) for capsule endoscopy and 4 per cent (CI, 0.5-12.0%) for SBS. These point estimates of
diagnostic yield were surrounded by wide credibility intervals due to the limited quantity of SBS data available.
Despite this fact, the odds ratio of diagnostic yield of capsule endoscopy versus SBS was statistically significant
(37.3 CI, 9.43-270.97) and favoured capsule endoscopy,
In summary based on the available evidence capsule endoscopy has a significantly greater diagnostic yield
compared with SBS radiology.

NICE Interventional Procedures Overview: Wireless capsule endoscopy Page 24 of 26

HTA Review: Blue Cross Blue Shield Association Wireless capsule endoscopy for obscure digestive tract
bleeding.
Literature search date: July 2002
This review reports on three published studies including a total of 72 subjects. Two of these studies were
conducted in patients with obscure digestive tract bleeding suspected to be of small bowel origin, and the third
study was conducted in patients with suspected small-bowel disease, most of whom had obscure digestive tract
bleeding.
Conclusions
The body of evidence is relatively small; however obscure digestive tract bleeding suspected to be of small-bowel
origin is a relatively infrequent condition and thus the availability of subjects for investigation may be limited.
No significant complications from wireless capsule endoscopy were reported in these studies.
The findings of the two comparative studies illustrated that wireless capsule endoscopy demonstrates additional
small bowel lesions generally beyond the reach of conventional push enteroscopy in 2550% of cases studies.
Wireless capsule endoscopy revealed additional suspicious or definite findings in 65100% of cases when
compared with small-bowel barium radiographic studies. In some cases, this additional information can lead to
changes in management that would improve health outcomes.

HTA Review: Blue Cross Blue Shield Association Wireless capsule endoscopy for small-bowel diseases other
than obscure GI bleeding.
Literature search date: November 2003 This review reports on three published studies, two abstracts and 9
relevant case reports included in 2 published case series.
Conclusions
For initial diagnosis of suspected Crohns disease when all conventional diagnostic tests including SBFT have
failed to reveal bowel lesions suggestive of Crohns disease, the evidence suggests that wireless capsule
endoscopy may demonstrate small-bowel lesions suggestive of Crohns disease in a significant proportion of
patients ranging from 4371%. Furthermore, patients diagnosed with Crohns disease by wireless capsule
endoscopy were reported to improve after treatment for Crohns disease, which represents an improvement in
health outcomes.
However the available evidence is not of sufficient quantity and quality to determine the relative diagnostic
performance of wireless capsule endoscopy compared with alternative conventional diagnostic tests in diagnosing
unselected patients with suspected Crohns disease. Thus no conclusions can be made as to whether wireless
capsule endoscopy is an effective alternative to conventional tests.

NICE Interventional Procedures Overview: Wireless capsule endoscopy Page 25 of 26

NICE Interventional Procedures Overview: Wireless capsule endoscopy Page 26 of 26
Appendix C: Literature search
The following search strategy was used to identify papers in Medline. A similar
strategy was used to identify papers in EMBASE, Current Contents, PredMedline and
all EMB databases.
For all other databases a simple search strategy using the key words in the title was
employed.

Search history
1 wireless capsule endoscopy.mp.
2 capsule endoscopy.mp.
3 videocapsule endoscopy.mp.
4
(camera adj4 pill).mp. [mp=title, abstract, cas registry/ec number word, mesh subject
eading] h
5 Wireless capsule enteroscopy.mp.
6 WCE.tw.
7
(Given$ adj4 capsule).mp. [mp=title, abstract, cas registry/ec number word, mesh
ubject heading] s
8 or/1-7
9 exp CAPSULES/
10 exp Video-Assisted Surgery/
11 exp Endoscopy, Gastrointestinal/
12 9 or 10
13 12 and 11
14 8 or 13
15 14 not 6