Clinical trial NCT01505842: Chromoendoscopy for Dysplasia Detection in Chronic Inflammatory Bowel Disease
Official title: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ulcerative Colitis
Crohn's Colitis
Keywords: Ulcerative colitis
Crohn's disease
Chromoendoscopy
Dysplasia
Neoplasia
Inflammatory Bowel Disease
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
First posted: 2012-01-09
Enrollment: 304
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Prevalence of dysplastic lesions
timeFrame: 12 month
Secondary outcomes:
measure: Number and rate of targeted and non-targeted biopsies detecting dysplasia and non-dysplasia
timeFrame: 12 month
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karoliniska University Hospital, Dept. of Gastroenterology
Study officials:
affiliation: Karolinska University Hospital
name: Peter T Schmidt, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alexandersson B, Hamad Y, Andreasson A, Rubio CA, Ando Y, Tanaka K, Ichiya T, Rezaie R, Schmidt PT. High-Definition Chromoendoscopy Superior to High-Definition White-Light Endoscopy in Surveillance of Inflammatory Bowel Diseases in a Randomized Trial. Clin Gastroenterol Hepatol. 2020 Aug;18(9):2101-2107. doi: 10.1016/j.cgh.2020.04.049. Epub 2020 Apr 27.