Chromoendoscopy for Dysplasia Detection in Chronic Inflammatory Bowel Disease

Study Overview
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Brief Summary
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Patients with longstanding ulcerative colitis or crohn's disease in the large bowel have an increased risk of developing cancer. The purpose of this study is to determine if visualizing of the mucosa in details using a dye spray (indigo-carmine) will result in detection of more abnormalities than conventional colonoscopy without dye spray.

Detailed Description
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Background: Patients with ulcerative colitis and Crohn's colitis are at increased risk of colon cancer. The usefulness of chromoendoscopy is debated. Previous studies are either based on magnifying endoscopy or on non-randomized trials. Some guidelines recommend chromoendoscopy with targeted biopsies and some normal colonoscopy with up to 40 random biopsies. Chromoendoscopy has the ability to identify subtle lesions that are otherwise missed by standard endoscopy. Whether chromoendoscopy with targeted biopsies can replace standard colonoscopy with random biopsies in the surveillance of patients with chronic colitis is unknown. Aim: In a RCT in surveillance colonoscopies in patients with ulcerative colitis or Crohn's colitis, we will determine if chromoendoscopy using a dilute solution of Indigo-carmine will improve dysplasia detection rate compared with colonoscopy without chromoendoscopy. Methods: After informed consent patients undergoing surveillance colonoscopy will be randomized to be examined by the study or control method. The study method will employ a 0.2-0.5% Indigo-Carmine solution sprayed over the colonic and rectal mucosa. The control method will be colonoscopy without Indigo-Carmine chromoendoscopy. In both the study arm and the control arm all subjects will have 32 random biopsies taken (4 from each of 8 defined segments of the colon) and biopsies from suspicious mucosa.

Official Title
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Randomized Controlled Trial (RCT) to Compare Dysplasia Detection Rate in Colonoscopy Without Chromoendoscopy Versus Colonoscopy With Chromoendoscopy in Detecting Dysplasia in Ulcerative Colitis and Crohn's Colitis Patients.

Conditions
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Ulcerative Colitis, Crohn's Colitis

Intervention / Treatment
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* Procedure: Colonoscopy with Indigo-Carmine chromoendoscopy
* Procedure: Conventional white-light colonoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with ulcerative colitis or Crohn's colitis satisfying criteria for surveillance colonoscopy: Ulcerative colitis, extensive > 8 years OR Crohn's colitis involving ≥ 1/3 of colon/rectum history of PSC or history of previous dysplasia on colon biopsies or family history of colon cancer in first degree relative Exclusion Criteria: Patients who decline to participate Unable to give informed consent Increased risk of bleeding (i.e. Warfarin, bleeding disorders, Clopidogrel)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Colonoscopy with chromoendoscopy<br>Colonoscopy with chromoendoscopy using 0.2-0.5% Indigo-Carmine solution sprayed in the whole colon and rectum plus 32 random biopsies plus biopsies from suspicious areas | Procedure: Colonoscopy with Indigo-Carmine chromoendoscopy<br>* Colonoscopy with chromoendoscopy using 0.2-0.5% Indigo-Carmine solution sprayed in the whole colon and rectum plus 32 random biopsies plus biopsies from suspicious areas<br>* Other names: Indigo-Carmine;|
| Active Comparator: Conventional colonoscopy<br>White light colonoscopy plus 32 random biopsies plus biopsies from suspicious areas | Procedure: Conventional white-light colonoscopy<br>* White light colonoscopy plus 32 random biopsies plus biopsies from suspicious areas<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of dysplastic lesions | Number of patients with dysplastic lesions by colonoscopy with chromoendoscopy using Indigo-carmine versus colonoscopy without chromoendoscopy | 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and rate of targeted and non-targeted biopsies detecting dysplasia and non-dysplasia |  | 12 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ulcerative colitis, Crohn's disease, Chromoendoscopy, Dysplasia, Neoplasia, Inflammatory Bowel Disease