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Chromoendoscopy for Dysplasia Detection in Chronic Inflammatory Bowel Disease

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.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01505842
Enrollment
304
Registered
2012-01-09
Start date
2011-02-28
Completion date
2019-04-04
Last updated
2019-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's Colitis, Ulcerative Colitis

Keywords

Ulcerative colitis, Crohn's disease, Chromoendoscopy, Dysplasia, Neoplasia, Inflammatory Bowel Disease

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.

Interventions

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

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

Sponsors

Karolinska University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of dysplastic lesions12 monthNumber of patients with dysplastic lesions by colonoscopy with chromoendoscopy using Indigo-carmine versus colonoscopy without chromoendoscopy

Secondary

MeasureTime frame
Number and rate of targeted and non-targeted biopsies detecting dysplasia and non-dysplasia12 month

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026