Chromoendoscopy for Dysplasia Detection in Chronic Inflammatory Bowel Disease

Not Applicable

• Conditions: Ulcerative Colitis; Crohn's Colitis
• Interventions: Procedure: Conventional white-light colonoscopy; Procedure: Colonoscopy with Indigo-Carmine chromoendoscopy

• Registration Number: NCT01505842
• Lead Sponsor: Karolinska University Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-12-29
• Study First Submitted QC: 2012-01-04
• Study First Posted: 2012-01-09
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-04
• Last Update Posted: 2019-03-06
• Primary Completion: 2019-04-04
• Study Completion: 2019-04-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 304

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional colonoscopy	Conventional white-light colonoscopy	White light colonoscopy plus 32 random biopsies plus biopsies from suspicious areas
Colonoscopy with chromoendoscopy	Colonoscopy with Indigo-Carmine chromoendoscopy	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

Primary Outcome Measures

Name	Time	Method
Prevalence of dysplastic lesions	12 month	Number of patients with dysplastic lesions by colonoscopy with chromoendoscopy using Indigo-carmine versus colonoscopy without chromoendoscopy

Secondary Outcome Measures

Name	Time	Method
Number and rate of targeted and non-targeted biopsies detecting dysplasia and non-dysplasia	12 month

Trial Locations

Locations (1)

Karoliniska University Hospital, Dept. of Gastroenterology; 🇸🇪 Stockholm, Sweden