Evaluation of the Applicability of the CDEIS to Data Obtained by the Colonic Capsule Endoscopy in Crohn Disease
NCT ID: NCT01183845
Last Updated: 2015-04-28
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
24 participants
INTERVENTIONAL
2009-04-30
2012-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Wireless Capsule Endoscopy in Small-Bowel Crohn's Disease
NCT00178438
Crohn's Disease Endoscopic REmission Definition in an Objective Way
NCT03498625
Endoscopic Severity Score of Small Bowel Crohn's Disease With Wireless Capsule Endoscopy
NCT00492791
Clinical Study Comparing PillCamĀ® Crohn's Capsule Endoscopy to Ileocolonoscopy (IC) Plus MRE for Detection of Active CD in the Small Bowel and Colon in Subjects With Known CD and Mucosal Disease.
NCT03241368
CE-U and MRE to Predict the Efficacy of Anti-TNF Therapy in Crohn's Disease
NCT01183403
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* 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
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Exam with colon capsule
Colon Capsule Endoscopy
Colon Capsule Endoscopy
Ileocolonic endoscopy scheduled; then colon capsule endoscopy performed.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Colon Capsule Endoscopy
Ileocolonic endoscopy scheduled; then colon capsule endoscopy performed.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
LEMANN Marc
Role: STUDY_DIRECTOR
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Alain ATTAR, MD
Role: PRINCIPAL_INVESTIGATOR
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hopital Beaujon
Clichy, , France
Chru Lille
Lille, , France
Chu Nantes
Nantes, , France
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Itzkowitz 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.
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.
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. doi: 10.1053/j.gastro.2003.11.010.
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. doi: 10.1111/j.1572-0241.2005.00274.x.
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. doi: 10.1055/s-2006-944832.
Schoofs 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.
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. doi: 10.1136/gut.30.7.983.
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 Therapeutique des Affections Inflammatoires Digestives. Gastroenterology. 1990 Apr;98(4):811-8. doi: 10.1016/0016-5085(90)90002-i.
Related Links
Access external resources that provide additional context or updates about the study.
Related Info
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GETAID 2008-2
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.