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 Reference Leighton JA, Shen B, Baron TH, et al; Standards of Practice Committee, American Society for Gastrointestinal Endoscopy. ASGE guideline: endoscopy in the diagnosis and treatment of inflammatory bowel disease. Gastrointest Endosc. 2006;63(4):558-565. 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 The patency capsule is a self-dissolving capsule that is the same size as the video capsule. It contains a radiofrequency identification tag that permits it to be detected by a scanning device placed on the abdominal wall. When its passage is blocked by a stenosis, the patency capsule dissolves 40–80 hours after ingestion. Reference Lichtenstein GR, Hanauer S, Sandborn WJ; Practice Parameters Committee of American College of Gastroenterology. Management of Crohn’s disease in adults. Am J Gastroenterol. 2009:104(2):465-483. 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 Reference Rey JF, Ladas S, Alhassani A, Kuznetsov K; ESGE Guidelines Committee. European Society of Gastrointestinal Endoscopy (ESGE). Video capsule endoscopy: update to guidelines (May 2006). Endoscopy. 2006;38(10):1047-1053. 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 Established in 2002 by Given Imaging, the International Conference on Capsule Endoscopy™ (ICCE™) is the world's preeminent symposium for the exchange of scientific, clinical, and practical information about PillCam® capsule endoscopy. In 6 years, there have been more than 1700 attendees and more than 40 countries represented. The ICCE annual meeting has taken place both in the United States and in Rome, Italy; Paris, France; Berlin, Germany; and Madrid, Spain. The next meeting will take place in August 2010, in Paris The ICCE involves scientific presentations describing the clinical picture that CE provides to the GI community. Global leaders share their experience with CE and encourage expanded indications for this procedure. References Kornbluth A, Colombel JF, Leighton JA, et al. ICCE consensus for inflammatory bowel disease. Endoscopy. 2005;37(10):1051-1054. Mergener K, Ponchon T, Gralnek I, et al. Literature review and recommendations for clinical application of small-bowel capsule endoscopy, based on a panel discussion by international experts. Consensus statements for small-bowel capsule endoscopy, 2006/2007. Endoscopy. 2007;39(10):895-909. 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 References 1. Mergener K, Ponchon T, Gralnek I, et al. Literature review and recommendations for clinical application of small-bowel capsule endoscopy, based on a panel discussion by international experts. Consensus statements for small-bowel capsule endoscopy, 2006/2007. Endoscopy. 2007;39(10):895-909. 2. Kornbluth A, Colombel JF, Leighton JA, et al. ICCE consensus for inflammatory bowel disease. Endoscopy. 2005;37(10):1051-1054. 1. Mergener K et al. Endoscopy. 2007;39(10):895-909. 2. Kornbluth A et al. Endoscopy. 2005;37(10):1051-1054.

Algorithm for the approach to suspected small-bowel CD Algorithm for the approach to suspected small-bowel CD. The absence of any mucosal lesions demonstrated by a complete assessment of the small bowel by CE excludes active CD of the small bowel. Patients with symptoms suggestive of obstruction, or known to have a stenosis, should either undergo a patency capsule examination or evaluation by CTE or magnetic resonance enterography (MRE) before capsule endoscopy. Reference Mergener K, Ponchon T, Gralnek I, et al. Literature review and recommendations for clinical application of small-bowel capsule endoscopy, based on a panel discussion by international experts. Consensus statements for small-bowel capsule endoscopy, 2006/2007. Endoscopy. 2007;39(10):895-909.

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 post-operative 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 Reference Kornbluth A, Colombel JF, Leighton JA, et al. ICCE consensus for inflammatory bowel disease. Endoscopy. 2005;37(10):1051-1054. 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