Chromoendoscopy for Dysplasia Detection in Chronic Inflammatory Bowel Disease

Karolinska University Hospital

Status: Unknown

Conditions: Ulcerative Colitis; Crohn's Colitis

Treatments: Procedure: Colonoscopy with Indigo-Carmine chromoendoscopy; Procedure: Conventional white-light colonoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT01505842

PTS-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 304 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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304 participants in 2 patient groups

Colonoscopy with chromoendoscopy

Experimental group

Description:

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

Treatment:

Procedure: Colonoscopy with Indigo-Carmine chromoendoscopy

Conventional colonoscopy

Active Comparator group

Description:

White light colonoscopy plus 32 random biopsies plus biopsies from suspicious areas

Treatment:

Procedure: Conventional white-light colonoscopy