Role of Capsule Endoscopy in the Evaluation of Mucosal Changes During Treatment of Patients With Active Crohn's Disease

NCT02193802 | Unknown

• 2 other identifiers: GETAID 2012-32013-A00034-41
• Study Type: interventional
• Target: 42
• Locations: 2 countries
• Sites: 11

Brief Summary

The utility of capsule endoscopy in diagnosing small bowel (SB) Crohn's disease has been demonstrated in a number of studies. 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.

Conditions

Crohn's Disease

Keywords

Crohn's disease; small bowel (SB); capsule endoscopy; ileocolonoscopy; anti-TNF-alpha antibodies

Outcome Measures

Primary Outcomes (1)

• Evaluate the agreement between capsule and ileocolonoscopy in the change of physician global assessment (PGA) as visualized in the TI in patients under treatment.

  PGA will be evaluated based on capsule or Ileocolonoscopy procedures at week 0 and after 6 at 12 months in two ways as follows: Quantitative PGA assessment: the severity of the disease will be graded on an analogue visual scaled from 0 (no lesions identified) to 10 (lesions of maximum severity identified). Qualitative PGA assessment: the severity of the disease at weeks 0 and 40 will be classified into one of the following categories: * No active disease * Mild disease * Moderate disease * Severe disease Physician global assessment of the disease severity variation will be classified into: * Definite Improvement * Slightly improvement * No change * Slightly worsening * Definite Worsening Disease severity variation will be also quantified by the change in quantitative PGA. The disease global severity will be later estimated by the two independent local investigators based on the previously capsule small bowel PGA and on the colonoscopy previously colon PGA.

  week 0 and after 6 at 12 months

Secondary Outcomes (2)

• Lewis score

  week 0 and after 6 at 12 months

• Segmental ileal and global CDEIS score

  week 0 and after 6 at 12 months

Study Arms (1)

Endoscopy

OTHER

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.

Device: PillCam® COLON 2 and PillCam Crohn's capsules

Interventions

PillCam® COLON 2 and PillCam Crohn's capsules DEVICE

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.

Endoscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject aged more than 18 years
• 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

You may not qualify if:

• Known gastrointestinal obstruction or strictures based on the clinical picture or pre procedure testing and profile
• 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

Sponsors & Collaborators

• Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives: lead

Study Sites (11)

CHU Amiens

Amiens, 80054, France

Location

CHU CAEN

Caen, 14033, France

Location

CHU Clermont Ferrand

Clermont-Ferrand, 63003, France

Location

Hôpital Beaujon

Clichy, 92 110, France

Location

CHU Kremlin Bicêtre

Le Kremlin-Bicêtre, 94270, France

Location

Hôpital Huriez

Lille, 59000, France

Location

Hôpital Brabois

Nancy, 54000, France

Location

Hôpital Hôtel Dieu

Nantes, 44093, France

Location

Hôpital Archet 2

Nice, 06200, France

Location

Hôpital St Louis

Paris, 75010, France

Location

Hospital Clinic

Barcelona, 08036, Spain

Location

Related Publications (17)

• 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.

  BACKGROUND

• Lichtenstein G.R. The Clinician's Guide to Inflammatory Bowel Disease. Slack Publishers, New Jersey 2003. pps 1-7;16-19; 41-57.

  BACKGROUND

• 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.

  PMID: 16189789 BACKGROUND

• Engstrom P.F. Goosenberg E.B. Diagnosis and Management of Bowel Disease. 1st edition. Professional Communications, Inc. Publisher. Oklahoma. 1999. pps. 169-185.

  BACKGROUND

• 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.

  PMID: 18022866 BACKGROUND

• 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.

  PMID: 12786607 BACKGROUND

• 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.

  PMID: 16189768 BACKGROUND

• 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.

  PMID: 15017630 BACKGROUND

• 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.

  PMID: 17725961 BACKGROUND

• 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.

  PMID: 20029412 BACKGROUND

• 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.

  PMID: 20210770 BACKGROUND

• 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.

  PMID: 10220494 BACKGROUND

• 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.

  PMID: 12047962 BACKGROUND

• 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.

  PMID: 20393175 BACKGROUND

• 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.

  PMID: 16500392 BACKGROUND

• 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.

  PMID: 16185968 BACKGROUND

• 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.

  PMID: 18320313 BACKGROUND

Related Links

• sponsor link

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Dr Arnaud Bourreille, MD

  CHU Nantes, Service Hépato-gastro-entérologie 1, place Alexis Ricordeau 44093 Nantes Cedex 1

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2014
• First Posted: July 18, 2014
• Study Start: May 1, 2014
• Primary Completion: December 30, 2021
• Study Completion: March 1, 2022
• Last Updated: July 9, 2021

Record last verified: 2021-07

Locations

ES (1); FR (10)