Role of Capsule Endoscopy (CE) in the Diagnosis and Monitoring of

Report
Practice Guidelines and
Consensus on Capsule Endoscopy
5-000-490
Indications for Use
• PillCam® SB is intended for visualization of the small
bowel mucosa. It may be used as a tool in the
detection of abnormalities of the small bowel in adults
and children from two years of age and up.
• The Suspected Blood Indicator (SBI) feature is intended
to mark frames of the video suspected of containing
fresh blood or red areas.
Contraindications
Contraindications for the PillCam SB include:
• Patients with known or suspected GI obstruction,
strictures, or fistulas based on the clinical picture or
pre-procedure testing and profile.
• Patients with cardiac pacemakers or other implanted
electro-medical devices.
• Patients with swallowing disorders.
Procedure Risk Information
• The risks of PillCam capsule endoscopy include capsule
retention, aspiration, or skin irritation. The risks of the
Agile™ GI patency test include capsule retention and
aspiration. Endoscopic placement may present
additional risks. Medical, endoscopic, or surgical
intervention may be necessary to address any of these
complications, should they occur.
• After ingesting the PillCam SB capsule and until it is
excreted, the patient should not be near any source of
powerful electromagnetic fields such as one created
near an MRI device.
• Please refer to the User Manual or
www.givenimaging.com for detailed information.
ASGE Position on Capsule Endoscopy
• Capsule endoscopy (CE) is a less invasive technique
for evaluating the small intestine for Crohn’s
involvement
• Shown to be more sensitive than radiologic and
endoscopic procedures for detecting small bowel
lesions
Leighton JA et al. Gastrointest Endosc. 2006;63(4):558-565.
American College of Gastroenterology
• In prospective, blinded evaluations, CE was
demonstrated to be superior in its ability to detect
small bowel pathology missed on small bowel radiologic
studies and computed tomography (CT) radiologic
examinations
• Small bowel strictures are considered a
contraindication for CE
• Capsule retention reported to occur in up to 13% of patients
with known long-term Crohn’s disease
• Patency capsules are available to assess the potential of
retention resulting from a stricture
• Small bowel follow-through, CT enterography, or magnetic
resonance (MR) enterography recommended before CE
Lichtenstein GR et al. Am J Gastroenterol. 2009:104(2):465-483.
European Society of Gastrointestinal Endoscopy
• Valuable tool in the diagnosis of small bowel diseases,
especially bleeding lesions and CD
• High yield in finding small bowel lesions in CD
• Permits confirmation of diagnosis of small bowel CD when the
diagnosis was not possible by other conventional means
• Detected more proximal and middle small bowel cases of CD
than did CT enterography and SBFT
• Limitations: false-positive/-negative results (image
angle accuracy), no tissue sampling, inter-observer
variability, risk of retention
Rey JF et al. Endoscopy. 2006;38(10):1047-1053.
OMED-ECCO Consensus in the Management of
Patients with IBD
• Small bowel CE (SBCE) should be reserved for cases in which
ileocolonoscopy plus small bowel radiography is not diagnostic, but
the suspicion of Crohn’s disease remains high
• SBCE may be better than small bowel follow-through or
enteroclysis at identifying small bowel mucosal lesions consistent
with Crohn’s disease
• SBCE may be superior to MR enterography for detection of mucosal
lesions consistent with Crohn’s disease
• SBCE may be superior to CTE or CT enteroclysis for detection of
mucosal lesions consistent with Crohn’s disease
Bourreille et al. Endoscopy 2009;41:618-637.
International Conference on Capsule Endoscopy™
(ICCE™) Consensus for Crohn’s Disease
• CE may play an important role in the evaluation of
some patients with known or suspected CD1
• More sensitive for assessing small bowel mucosal lesions
in adult and pediatric patients than any other imaging
technique1,2
• Shown to be superior to ileoscopy, push enteroscopy, small
bowel radiography (SBFT and enteroclysis), CT enterography,
and small-bowel MR imaging
• Negative CE findings in pediatric patients could likely
exclude CD, whereas other imaging techniques tend to
yield higher numbers of false-positive results
1. Kornbluth A et al. Endoscopy. 2005;37(10):1051-1054.
2. Mergener K et al. Endoscopy. 2007;39(10):895-909.
International Conference on Capsule Endoscopy
(ICCE) Consensus for Crohn’s Disease (continued)
• Can be a useful adjunctive test (e.g., with
colonoscopy with ileoscopy) to discriminate between
CD and UC in patients with IC1,2
• Can identify small bowel lesions better than other imaging
methods; more sensitive than serological markers
• CE can lead to changes in therapy based on the
extent and/or severity of the inflammation found in
the small bowel1
1. Mergener K et al. Endoscopy. 2007;39(10):895-909.
2. Kornbluth A et al. Endoscopy. 2005;37(10):1051-1054.
International Conference on Capsule Endoscopy
(ICCE) Conclusions
• CE can identify small bowel mucosal lesions not seen
with other imaging modalities and may, therefore, play
an important role in the evaluation of patients with
known or suspected CD
• For known CD, CE may be useful in the evaluation of
unexplained symptoms
• May also prove to be of value in the evaluation of IC
• May have a unique role in assessing mucosal healing
after medical therapy and for assessing early postoperative recurrence and for guiding therapy
• May serve as a subclinical marker in asymptomatic
family members and may contribute to the
understanding of the natural history of IBD
Kornbluth A et al. Endoscopy. 2005;37(10):1051-1054.
Practice Guidelines Key Points
• CE is a less invasive technique for evaluating the
small intestine for Crohn’s involvement
• In prospective, blinded evaluations, CE was
demonstrated to be superior in its ability to detect
small bowel pathology missed on small bowel
radiologic studies and CT radiologic examinations
• Small bowel CE (SBCE) should be reserved for cases in
which ileocolonoscopy plus small bowel radiography is
not diagnostic, but the suspicion of Crohn’s disease
remains high
• CE can lead to changes in therapy based on the
extent and/or severity of the inflammation found in
the small bowel

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