Evaluation of the Applicability of the CDEIS to Data Obtained by the Colonic Capsule Endoscopy in Crohn Disease
CAPSCOL
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
1 other identifier
interventional
24
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Apr 2009
Typical duration for phase_4
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 11, 2009
CompletedFirst Posted
Study publicly available on registry
August 18, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedApril 28, 2015
August 1, 2011
3.2 years
September 11, 2009
April 26, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Data obtained by the colon capsule endoscopy as a Measure of safety
1 month
Secondary Outcomes (2)
Reproducibility of the identification of the different anatomic segments on the CCE recordings
1 month
Reproducibility of the detection of each lesion
At inclusion
Study Arms (1)
Exam with colon capsule
EXPERIMENTALColon Capsule Endoscopy
Interventions
Ileocolonic endoscopy scheduled; then colon capsule endoscopy performed.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Hopital Beaujon
Clichy, 92110, France
Chru Lille
Lille, 59037, France
Chu Nantes
Nantes, 44093, France
Related Publications (10)
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. doi: 10.1111/j.1572-0241.2005.00360.x.
PMID: 16393228RESULTItzkowitz SH, Harpaz N. Diagnosis and management of dysplasia in patients with inflammatory bowel diseases. Gastroenterology. 2004 May;126(6):1634-48. doi: 10.1053/j.gastro.2004.03.025.
PMID: 15168373RESULTRutgeerts 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: 16500392RESULTRutter 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. doi: 10.1053/j.gastro.2003.11.010.
PMID: 14762782RESULTTriester 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. doi: 10.1111/j.1572-0241.2005.00274.x.
PMID: 16279893RESULTKahn JL, Sick H, Laude M, Koritke JG. [Vascularization of the adipose body of the cheek]. Arch Anat Histol Embryol. 1990;73:3-20. French.
PMID: 1669678RESULTEliakim 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. doi: 10.1055/s-2006-944832.
PMID: 17058158RESULTSchoofs N, Deviere 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. doi: 10.1055/s-2006-944835.
PMID: 17058159RESULTMary 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. doi: 10.1136/gut.30.7.983.
PMID: 2668130RESULTModigliani 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 Therapeutique des Affections Inflammatoires Digestives. Gastroenterology. 1990 Apr;98(4):811-8. doi: 10.1016/0016-5085(90)90002-i.
PMID: 2179031RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
LEMANN Marc
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
- PRINCIPAL INVESTIGATOR
Alain ATTAR, MD
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 11, 2009
First Posted
August 18, 2010
Study Start
April 1, 2009
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
April 28, 2015
Record last verified: 2011-08