Role of Capsule Endoscopy in the Evaluation of Mucosal Changes During Treatment of Patients With Active Crohn's Disease
NCT ID: NCT02193802
Last Updated: 2021-07-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
42 participants
INTERVENTIONAL
2014-05-31
2022-03-31
Brief Summary
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Mucosal healing is a good predictor of long term remission. Unfortunately, the assessment of small bowel mucosal healing by conventional colonoscopy is an invasive technique which is not complete since it does not allow exploration of the small bowel beyond the terminal ileum (TI). Thus, direct evidence of the healing of the majority of the small bowel is lacking.
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Detailed Description
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The disease affects populations around the globe and occurs at any age but tends to have a peak incidence between the ages of 15 and 35. Typical presenting symptoms include abdominal pain and diarrhea. The clinical presentation of Crohn's disease fluctuates throughout the course of the disease. Symptoms and signs usually correlate with mucosal inflammation. The pattern of Crohn's disease viewed on endoscopy has been characterized and is associated with a number of mucosal characteristics such as erythema, swelling, nodularity, strictures, aphthoid ulceration and ulcers of variable size and depth.
The utility of capsule endoscopy in diagnosing small bowel (SB) Crohn's disease has been demonstrated in a number of studies. Diagnostic yields of 70% have been reported in suspected SB Crohn's disease. In patients with a known Crohn's disease, the superiority of the capsule to detect mucosal lesions of the SB in comparison to any other radiologic technique has also been clearly demonstrated.
A number of studies indicate that mucosal healing is a good predictor of long term remission. In particular, intense therapeutic regimens including purine analogues and biologic therapies like infliximab have been associated with endoscopic mucosal healing. The recently published SONIC trial evaluated the efficacy of infliximab monotherapy, azathioprine monotherapy and the two drugs combined in moderate to severe Crohn's disease patients. Patients who were treated with infliximab monotherapy and with the combination therapy had significantly longer corticosteroid-free clinical remission than those receiving azathioprine alone. Furthermore, mucosal healing, defined as the absence of mucosal ulcerations at week 26, was greater for the combination therapy than each of the monotherapies alone. Based on the results of these studies, obtaining a mucosal healing becomes in clinical practice a new therapeutic objective especially in patients treated by immunosuppressors or anti-TNF-alpha antibodies. In most of the studies, a complete mucosal healing was assessed by the complete disappearance of ulceration. An endoscopic response could be evaluated by the variation of several endoscopic scores of severity, that are either dedicated to the terminal ileon (TI) more the colon i.e. the Crohn's disease endoscopic severity index (CDEIS) or to the SB i.e. the Lewis score. Concerning the evaluation of the mucosal lesions of the SB by the capsule, a new index of severity is being developed in a study conducted by the different centers of the GETAID i.e. the CE-CDEIS. This score will be available in the first semester of 2013 and would be usable for the present study.
Unfortunately, the assessment of mucosal healing by conventional ileocolonoscopy is not complete since it does not allow exploration of the small bowel beyond TI. Thus, while mucosal changes and symptomatic improvement in subjects with SB Crohn's disease (with or without colonic involvement) can be inferred from studies like ACCENT I, direct evidence of the healing of the majority of the small bowel is lacking. In addition, correlation between evidence of mucosal healing and symptoms, as measured by the Crohn's Disease Activity Index (CDAI), has not been found reliable. This may reflect the limitation of viewing the full extent of small bowel ulcerations on the limited examination which is possible with ileocolonoscopy. This may potentially be overcome with the use of capsule endoscopy of the small bowel.
Until now, no study has evaluated the potential treatment-induced changes of the mucosal lesions located in the SB with a capsule and no comparison between the capsule and the ileocolonoscopy has been conducted in the evaluation of the TI which is the segment analyzable by both techniques. For the patients, demonstrate that the capsule is usable to evaluate the mucosal healing, would be a considerable benefit knowing that the capsule do not necessitate an arduous bowel cleansing and a sedation or a general anesthesia.
The proposed study is designed as a pilot study to evaluate the role of capsule endoscopy in Crohn's disease patients, in monitoring the changes in the terminal ileum and small bowel mucosa during Crohn's disease treatment for induction of remission in active Crohn's disease with ileal involvement. Success in this trial may lead to a larger trial to validate the findings.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Endoscopy
CHANCE is a single arm study: all patients will undergo one capsule endoscopy ( PillCam® COLON 2 capsule and PillCam Crohn's) of the whole intestine AND one ileocolonoscopy.
The patients will be then treated according to the preference of their physician and a second capsule endoscopy AND an ileoconoscopy will be performed 6 at 12 months later.
Both exams will be evaluated locally by two independent investigators and all the recorded films will be evaluated and compared by four central readers.
PillCam® COLON 2 and PillCam Crohn's capsules
Patient preparation for PillCam® COLON 2 and PillCam Crohn's capsule procedure:
Patients will drink only clear liquids beginning 12 noon the day prior to the procedure,12 hour fast prior to the procedure and 1 L of PEG on the morning two hours before the capsule ingestion.
Patients can drink clear liquids 2 hours and eat 4 hours post ingestion. Eight hours post ingestion the data recorder should be removed. Patients will confirm excretion of the capsule or as required by the investigator.
Interventions
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PillCam® COLON 2 and PillCam Crohn's capsules
Patient preparation for PillCam® COLON 2 and PillCam Crohn's capsule procedure:
Patients will drink only clear liquids beginning 12 noon the day prior to the procedure,12 hour fast prior to the procedure and 1 L of PEG on the morning two hours before the capsule ingestion.
Patients can drink clear liquids 2 hours and eat 4 hours post ingestion. Eight hours post ingestion the data recorder should be removed. Patients will confirm excretion of the capsule or as required by the investigator.
Eligibility Criteria
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Inclusion Criteria
* Subject with at least ileal lesions of Crohn's disease
* Subject with moderate to severe Crohn's disease at baseline, as defined by CDAI \> 150,
* Subject accepting to undergo two capsules endoscopy and Ileocolonoscopy procedures
* Proven patency by Agile capsule or another approach deemed clinically acceptable by the investigator, e.g. CT enterography or MRI enterography, performed within the 6 months prior to enrollment
Exclusion Criteria
* Cardiac pacemakers or other implanted electromedical devices
* Swallowing disorders.
* Subject with known slow gastric emptying
* Contraindications to ileocolonoscopy or general anasthesia
* Subject with any condition, which precludes compliance with study and/or device instructions
* Women who are either pregnant or nursing at the time of screening, who intend to be during the study period, or are of child-bearing potential and do not practice medically acceptable methods of contraception.
* Subject suffers from life threatening conditions
* Subject currently participating in another clinical study
* Subject has taken NSAID medications less than one month before enrollment
18 Years
ALL
No
Sponsors
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Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
OTHER
Responsible Party
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Principal Investigators
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Dr Arnaud Bourreille, MD
Role: PRINCIPAL_INVESTIGATOR
CHU Nantes, Service Hépato-gastro-entérologie 1, place Alexis Ricordeau 44093 Nantes Cedex 1
Locations
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CHU Amiens
Amiens, , France
CHU CAEN
Caen, , France
CHU Clermont Ferrand
Clermont-Ferrand, , France
Hôpital Beaujon
Clichy, , France
CHU Kremlin Bicêtre
Le Kremlin-Bicêtre, , France
Hôpital Huriez
Lille, , France
Hôpital Brabois
Nancy, , France
Hôpital Hôtel Dieu
Nantes, , France
Hôpital Archet 2
Nice, , France
Hôpital St Louis
Paris, , France
Hospital Clinic
Barcelona, , Spain
Countries
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References
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Sands B.E. Crohn's Disease. Sleisenger and Fortran's Gastrointestinal and Liver Disease. 8th edition; Volume 2; Saunders Elsevier Publisher; Canada. 2006. pps 2459-2498.
Lichtenstein G.R. The Clinician's Guide to Inflammatory Bowel Disease. Slack Publishers, New Jersey 2003. pps 1-7;16-19; 41-57.
Kornbluth A, Colombel JF, Leighton JA, Loftus E; ICCE. ICCE consensus for inflammatory bowel disease. Endoscopy. 2005 Oct;37(10):1051-4. doi: 10.1055/s-2005-870315. No abstract available.
Engstrom P.F. Goosenberg E.B. Diagnosis and Management of Bowel Disease. 1st edition. Professional Communications, Inc. Publisher. Oklahoma. 1999. pps. 169-185.
Sipponen T, Savilahti E, Kolho KL, Nuutinen H, Turunen U, Farkkila M. Crohn's disease activity assessed by fecal calprotectin and lactoferrin: correlation with Crohn's disease activity index and endoscopic findings. Inflamm Bowel Dis. 2008 Jan;14(1):40-6. doi: 10.1002/ibd.20312.
Sostegni R, Daperno M, Scaglione N, Lavagna A, Rocca R, Pera A. Review article: Crohn's disease: monitoring disease activity. Aliment Pharmacol Ther. 2003 Jun;17 Suppl 2:11-7. doi: 10.1046/j.1365-2036.17.s2.17.x.
Lewis BS, Eisen GM, Friedman S. A pooled analysis to evaluate results of capsule endoscopy trials. Endoscopy. 2005 Oct;37(10):960-5. doi: 10.1055/s-2005-870353.
Mow WS, Lo SK, Targan SR, Dubinsky MC, Treyzon L, Abreu-Martin MT, Papadakis KA, Vasiliauskas EA. Initial experience with wireless capsule enteroscopy in the diagnosis and management of inflammatory bowel disease. Clin Gastroenterol Hepatol. 2004 Jan;2(1):31-40. doi: 10.1016/s1542-3565(03)00289-1.
Dray X, Vahedi K, Valleur P, Marteau P. Is there any need for video capsule endoscopy evaluation in postduodenal small-bowel polyps detection in familial adenomatous polyposis? Gastrointest Endosc. 2007 Sep;66(3):634; author reply 634-5. doi: 10.1016/j.gie.2007.04.008. No abstract available.
Dionisio PM, Gurudu SR, Leighton JA, Leontiadis GI, Fleischer DE, Hara AK, Heigh RI, Shiff AD, Sharma VK. Capsule endoscopy has a significantly higher diagnostic yield in patients with suspected and established small-bowel Crohn's disease: a meta-analysis. Am J Gastroenterol. 2010 Jun;105(6):1240-8; quiz 1249. doi: 10.1038/ajg.2009.713. Epub 2009 Dec 22.
van Assche G, Vermeire S, Rutgeerts P. Mucosal healing and anti TNFs in IBD. Curr Drug Targets. 2010 Feb;11(2):227-33. doi: 10.2174/138945010790309902.
D'haens G, Van Deventer S, Van Hogezand R, Chalmers D, Kothe C, Baert F, Braakman T, Schaible T, Geboes K, Rutgeerts P. Endoscopic and histological healing with infliximab anti-tumor necrosis factor antibodies in Crohn's disease: A European multicenter trial. Gastroenterology. 1999 May;116(5):1029-34. doi: 10.1016/s0016-5085(99)70005-3.
Hanauer SB, Feagan BG, Lichtenstein GR, Mayer LF, Schreiber S, Colombel JF, Rachmilewitz D, Wolf DC, Olson A, Bao W, Rutgeerts P; ACCENT I Study Group. Maintenance infliximab for Crohn's disease: the ACCENT I randomised trial. Lancet. 2002 May 4;359(9317):1541-9. doi: 10.1016/S0140-6736(02)08512-4.
Colombel JF, Sandborn WJ, Reinisch W, Mantzaris GJ, Kornbluth A, Rachmilewitz D, Lichtiger S, D'Haens G, Diamond RH, Broussard DL, Tang KL, van der Woude CJ, Rutgeerts P; SONIC Study Group. Infliximab, azathioprine, or combination therapy for Crohn's disease. N Engl J Med. 2010 Apr 15;362(15):1383-95. doi: 10.1056/NEJMoa0904492.
Rutgeerts P, Diamond RH, Bala M, Olson A, Lichtenstein GR, Bao W, Patel K, Wolf DC, Safdi M, Colombel JF, Lashner B, Hanauer SB. Scheduled maintenance treatment with infliximab is superior to episodic treatment for the healing of mucosal ulceration associated with Crohn's disease. Gastrointest Endosc. 2006 Mar;63(3):433-42; quiz 464. doi: 10.1016/j.gie.2005.08.011.
Dubcenco E, Jeejeebhoy KN, Petroniene R, Tang SJ, Zalev AH, Gardiner GW, Baker JP. Capsule endoscopy findings in patients with established and suspected small-bowel Crohn's disease: correlation with radiologic, endoscopic, and histologic findings. Gastrointest Endosc. 2005 Oct;62(4):538-44. doi: 10.1016/j.gie.2005.06.026.
Postgate AJ, Burling D, Gupta A, Fitzpatrick A, Fraser C. Safety, reliability and limitations of the given patency capsule in patients at risk of capsule retention: a 3-year technical review. Dig Dis Sci. 2008 Oct;53(10):2732-8. doi: 10.1007/s10620-008-0210-5. Epub 2008 Mar 5.
Related Links
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sponsor link
Other Identifiers
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2013-A00034-41
Identifier Type: OTHER
Identifier Source: secondary_id
GETAID 2012-3
Identifier Type: -
Identifier Source: org_study_id
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