Evaluation of the Applicability of the CDEIS to Data Obtained by the Colonic Capsule Endoscopy in Crohn Disease - Full Text View

Sponsor:	Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Information provided by (Responsible Party):	Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
ClinicalTrials.gov Identifier:	NCT01183845

Purpose

The Crohn's Disease Endoscopic Index of Severity is a validated index to assess the severity of ileocolonic lesions. Depth of ulcerations are evaluated in each segment of ileocolon and the surface of lesions and ulcerations are reported on a 10-cm analogic scale. The Crohn's Disease Endoscopic Index of Severity is the main score used in controlled trials to assess the endoscopic severity of lesions in Crohn's Disease.

The investigators aim to conduct a prospective pilot study primarily to evaluate the applicability of the Crohn's Disease Endoscopic Index of Severity to data obtained by the colonic capsule endoscopy procedure, provided that conventional ileo-colonoscopy and capsule endoscopy lead to comparable overall severity evaluations.

Secondary objectives are to assess reproducibility of the reading of data obtained by CCE and to compare these data with those obtained by conventional ileocolonoscopy. If overall severity evaluations derived from the two examinations are not comparable, the secondary objectives will be used in an attempt to understand the reasons of this discrepancy.

Condition	Intervention	Phase
Crohn Disease	Procedure: Colon Capsule Endoscopy	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	A Pilot Study to Evaluate the Applicability of the Crohn's Disease Endoscopy Index of Severity to Data Obtained by the Colonic Capsule Endoscopy in Ileocolonic Crohn's Disease

Resource links provided by NLM:

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease Endoscopy

U.S. FDA Resources

Further study details as provided by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives:

Primary Outcome Measures:

Data obtained by the colon capsule endoscopy as a Measure of safety [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Reproducibility of the identification of the different anatomic segments on the CCE recordings [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
Reproducibility of the detection of each lesion [ Time Frame: At inclusion ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	24
Study Start Date:	April 2009
Estimated Study Completion Date:	June 2012
Estimated Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Exam with colon capsule Colon Capsule Endoscopy	Procedure: Colon Capsule Endoscopy Ileocolonic endoscopy scheduled; then colon capsule endoscopy performed.

Detailed Description:

Twenty-four patients with CD will be included in the study on the basis of the need for an ileo-colonoscopy whatever the indication.

Males and females patients more than 18-years-old
Known colonic CD patients with a diagnosis based on established clinical, endoscopic, ra-diologic, and histologic criteria
Ileocolonoscopy scheduled
Patients' agreement for the CCE procedure to be performed within the week following the ileocolonoscopy.
Previous imaging of small bowel (one or more) by Small Bowel Follow Through (SBFT), Magnetic Resonance Enteroclysis (MRE) or Computed Tomography Enterography (CTE) performed in the last 12 months

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Males and females patients more than 18-years-old
Known colonic CD patients with a diagnosis based on established clinical, endoscopic, ra-diologic, and histologic criteria
Ileocolonoscopy scheduled
Patients' agreement for the CCE procedure to be performed within the week following the ileocolonoscopy

Exclusion Criteria:

Surgery of one or more segment of the colon or terminal ileum
Non colonic CD
High risk for capsule retention defined by the presence of clinically significant obstructive symptom related to intestinal or colonic stricture detected by small bowel imaging
Stenosis of the colon or ileum not passed by the colonoscope
Treatment with antiTNF or biotherapy after the ileocolonoscopy and before the CCE procedure

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01183845

Locations

France
Hopital Beaujon	Recruiting
Clichy, France, 92110
Contact: Yoram BOUHNIK, MD,PhD +33 1 40 87 56 00 yoram.bouhnik@bjn.aphp.fr
Principal Investigator: YORAM BOUHNIK, MD,PhD
Sub-Investigator: Alain ATTAR, MD
Sub-Investigator: Carmen STEFANESCU, MD
Sub-Investigator: Xavier TRETON, MD
Chru Lille	Recruiting
Lille, France, 59037
Contact: Jean-Frédéric COLOMBEL, MD,PhD +33 3 20 44 47 14 jean-frederic-colombel@chru-lille.fr
Contact: Géraldine MEULIN +33 3 20 44 56 20 g-meulin@chru-lille.fr
Principal Investigator: Jean-Frédéric COLOMBEL, MD,PhD
Sub-Investigator: Gwenola VERNIER-MASSOUILLE, MD
Chu Nantes	Recruiting
Nantes, France, 44093
Contact: Arnaud BOURREILLE, MD +33202400830 arnaud.boureille@chu-nantes.fr
Principal Investigator: Arnaud BOURREILLE, MD
Sub-Investigator: Mathurin FLAMANT, MD

Sponsors and Collaborators

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Investigators

Study Director:	LEMANN Marc	GETAID
Principal Investigator:	Alain ATTAR, MD	GETAID

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

Publications:

Casellas F, Vivancos JL, Sampedro M, Malagelada JR. Relevance of the phenotypic characteristics of Crohn's disease in patient perception of health-related quality of life. Am J Gastroenterol. 2005 Dec;100(12):2737-42.

Itzkowitz SH, Harpaz N. Diagnosis and management of dysplasia in patients with inflammatory bowel diseases. Gastroenterology. 2004 May;126(6):1634-48. Review.

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.

Rutter M, Saunders B, Wilkinson K, Rumbles S, Schofield G, Kamm M, Williams C, Price A, Talbot I, Forbes A. Severity of inflammation is a risk factor for colorectal neoplasia in ulcerative colitis. Gastroenterology. 2004 Feb;126(2):451-9.

Triester SL, Leighton JA, Leontiadis GI, Fleischer DE, Hara AK, Heigh RI, Shiff AD, Sharma VK. A meta-analysis of the yield of capsule endoscopy compared to other diagnostic modalities in patients with obscure gastrointestinal bleeding. Am J Gastroenterol. 2005 Nov;100(11):2407-18.

Kahn JL, Sick H, Laude M, Koritke JG. [Vascularization of the adipose body of the cheek] Arch Anat Histol Embryol. 1990;73:3-20. French.

Eliakim R, Fireman Z, Gralnek IM, Yassin K, Waterman M, Kopelman Y, Lachter J, Koslowsky B, Adler SN. Evaluation of the PillCam Colon capsule in the detection of colonic pathology: results of the first multicenter, prospective, comparative study. Endoscopy. 2006 Oct;38(10):963-70.

Schoofs N, Devière J, Van Gossum A. PillCam colon capsule endoscopy compared with colonoscopy for colorectal tumor diagnosis: a prospective pilot study. Endoscopy. 2006 Oct;38(10):971-7.

Mary JY, Modigliani R. Development and validation of an endoscopic index of the severity for Crohn's disease: a prospective multicentre study. Groupe d'Etudes Therapeutiques des Affections Inflammatoires du Tube Digestif (GETAID). Gut. 1989 Jul;30(7):983-9.

Modigliani R, Mary JY, Simon JF, Cortot A, Soule JC, Gendre JP, Rene E. Clinical, biological, and endoscopic picture of attacks of Crohn's disease. Evolution on prednisolone. Groupe d'Etude Thérapeutique des Affections Inflammatoires Digestives. Gastroenterology. 1990 Apr;98(4):811-8.

Responsible Party:	Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
ClinicalTrials.gov Identifier:	NCT01183845 History of Changes
Other Study ID Numbers:	GETAID 2008-2
Study First Received:	September 11, 2009
Last Updated:	August 30, 2011
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives:

Crohn Disease
Crohn's Disease Endoscopy Index of Severity
Colon Capsule Endoscopy
Crohn's Disease located in colon and/or ileum

Additional relevant MeSH terms:

Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis

Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on May 24, 2012