Tabla 3. Studies that assess the effectiveness of endoscopic capsule in Crohn´s disease
Author
and year
Description of study
Comparison test
Outcome classification
Key efficacy findings
CE
Additional comments
Comparator
Mean
score
Suspected primary Crohn´s disease
Eliakim et
al15 (2004)
-Prospective
-35 patients with suspected
CD
-95 procedures prior to entry
-3 months between
comparison procedures
-SBFT, entero-CT
-Colonoscopy and
ileoscopy to resolve
controversial results
between procedures.
-Blinded to CE
-2 gastroenterologists: one blinded to
radiological findings, the other also
blinded to clinical results.
-Positive findings: those considered to
explain the reason for referral
Diagnostic yield
Medically significant lesions:
77%
Patient management
No change in patient
management.
Ge et el16
(2004)
-Prospective
-20 patients with suspected
CD
-Mean duration of
symptoms: 6,5 years.
-Normal results in SBFT and
lower GI endoscopy 6
months before.
SBFT, lower GI
endoscopy
-2 gastroenterologists
-Does not report if they were blinded to
the results of other tests or clinical data.
Diagnostic yield
Diagnosis in 65% patients. The
mild lesions or early stages
account for 54% (mucosal
erosions and aphthas)
Capsule retention
3 patients
Marmo et
al18 (2005)
-Prospective
-31 patients with newly
diagnosed Crohn´s disease
(all verified by biopsy)
-Mean duration of
symptoms: 110 days
-Enteroclisis
-Radiologist blinded
to the results of other
tests and clinical
results.
-2 experienced observers blinded to the
results of other tests and clinical data.
-Nonspecific or negative were assigned to
no abnormalities or nonspecific findings
(isolated erythematosus spots, villous
dropout, enlarged folds, mucosal breaks)
Diagnostic yield
Overall: 71%
Terminal ileum: 89%
Capsule patients
3 patients
Chong et
al17 (2005)
-Prospective
-21 patients suspected to
have CD.
-Previously evaluated by
endoscopy, SBFT, CT of
abdomen, scintigraphy and
ileoscopy.
-2 weeks between CE and
comparison procedures
-Mean follow up 8,4 months
PE, Enteroclisis
(n=16)
-Enteroclisis blinded
to PE and clinical
data.
-2 gastroenterologists blinded to EP and
enteroclisis results (consensus).
-Does not report if it was blinded to
previous tests or clinical data.
Diagnostic yield
Abnormal findings interpreted
as CD: 19%
Management change
67%
Outcome changes
Improvement in symptoms: 38%
Diagnostic yield
Medically significant
lesions with SBFT: 23%
Medically significant
lesions with entero-TC:
23%
Exclusion of patients
with obstructions,
major surgery, use of
NSAIDS.
Doubts as to what are
medically significant
lesions.
65%
-Exclusion of patients
with prior obstruction,
evidence of strictures,
use NSAIDS.
-Doubts as to how
positive results were
assigned.
27,5%
Diagnostic yield
Overall: 25,8%
Terminal ileum: 37%
Capsule retention
No capsule retention
-Exclusion of patients
with stenosing or
fistulizing CD,
surgery, use NSAIDS
85%
Diagnostic yield
enteroclisis (n=16)
Abnormal findings
interpreted as CD: 6%
Diagnostic yield PE
0%
-Exclusion of patientes
taking NSAIDS
-Of the 4 patients with
abnormal findings on
CE only 2 had
enteroclysis.
-Unclear as to what
findings were
considered as CD
-No significant
differences between
groups (4 vs 0) (4 vs 1).
-No bowel cleansing
60%
Author
and year
Description of study
Comparison test
Outcome classification
Key efficacy findings
CE
Additional comments
Mean
score
Comparator
Established Crohn´s disease
Buchmann
et al19
(2004)
Prospective
-42 patients with prior
diagnosis of CD and
suspected recurrence.(no
prior surgery)
-12 excluded (stenosis)
-SBFT, clinical and
laboratory assessment
-Blinded to EC
-Lesions classified as grade 1,2 or 3
-Blinded to SBFT results but no indication
it it was blinded to clinical information
Diagnostic yield
-Active disease in 70%
-Positive results in 6 patients
with normal SBFT
-The results were not in
concordance with laboratory
assessment of activity.
Diagnostic yield SBFT
-Active disease in 67%
Positive in 5 patients
with normal CE
-No concordance with
laboratory assessment
of activity.
-Paper does not report
the characteristics of
patients included.
60%
Voderholzer
et al20
(2005)
-Prospective
-56 patients with CD (14
with previously iliocaecal
resection, 5 newly
established)
-15 excluded (stenosis)
-EGD,
ileocolonoscopy, CT
enteroclysis.
-Each technique
blinded to other
investigations.
-One investigator blinded to the results
of other investigations.
Diagnostic yield
-Small intestinal involvement:
61%
-Ileocecal/neoterminal
involvement: 58%
Diagnostic yield
enteroclysis CT
-Small intestine: 29%
-Ileocecal/neoterminal
involvement: 49%
Ileocolonoscopy
-Ileocecal/neoterminal:
involvement: 63%
-None of the patients
receiving NSAIDS.
-Bowel cleansing 15
minutes before.
77,5%
Chong et
al17
(2005)
-Prospective
-22 patients with known CD
-50% previous surgery
-PE (n=22),
Enteroclisis (n=21)
-Enteroclisis blinded
to PE and clinical
data.
-2 gastroenterologists blinded to EP and
enteroclisis results (consensus).
-Does not report if it was blinded to
previous tests or clinical data.
Diagnostic yield
Abnormal findings: 77%
Management change
73%
Outcome changes
Improvement in symptoms: 56%
Diagnostic yield
enteroclisis (n=16)
Abnormal findings
interpreted as CD: 19%
PE
14%
-Unclear as to what
findings were
considered as CD
-8/9 with
improvement had
negative CE results.
60%
Dubcenco
et al21
(2005)
-Prospective
-54 patients (43 with
established CD)
-15 excluded (estenosis=14)
-67,8% had surgery in
established CD group.
Ileocolonoscopy with
biopsies, SBFT
-Does not report if
they were blinded
-Study tests within 23 weeks of CE.
-Experienced investigator blinded to the
results of other tests and clinical data.
Diagnostic yield
66,6%
Accuracy (n=56)
S=89,6%, E=100%, PPV=100%,
NPV=76,9%
Diagnostic yield
SBFT
20,5%
Accuracy (n=56)
S=27,6%, E=100%,
PPV=100%,
NPV=23,3%
-Exclusion of patients
with suspected
obstruction and
patients that use
NSAIDS
85%
-No inclusion criteria
provided
-Doubts as to what
findings were
considered as CD.
30%
-No bowel preparation
85%
Pediatric patients with suspected Crohn´s disease
ArguellesArias et
al22
(2004)
-Prospective
-12 pediatric patients
suspected to have CD
-All with negative
colonoscopy, EGD, SBFT
-colonoscopy, EGD,
SBFT
-Not indicated
Diagnostic yield
Findings consistent with CD:
58,3%
Guilhon de
Araujo
Sant´Anna
et al23
(2005)
-Prospective
-20 pediatric patients
-Colonoscopy with
biopsy and SBFT
-4 weeks before CE
-2 observers (one blinded to clinical
history and previous investigations)
Diagnostic yield
Positive: 60%
Diagnostic yield
traditional
investigations:
Positive: 25%