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Chromoendoscopy for Dysplasia Detection in Chronic Inflammatory Bowel Disease

Primary Purpose

Ulcerative Colitis, Crohn's Colitis

Status
Unknown status
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Colonoscopy with Indigo-Carmine chromoendoscopy
Conventional white-light colonoscopy
Sponsored by
Karolinska University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Ulcerative Colitis focused on measuring Ulcerative colitis, Crohn's disease, Chromoendoscopy, Dysplasia, Neoplasia, Inflammatory Bowel Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Karoliniska University Hospital, Dept. of Gastroenterology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Colonoscopy with chromoendoscopy

Conventional colonoscopy

Arm 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

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

Outcomes

Primary Outcome Measures

Prevalence of dysplastic lesions
Number of patients with dysplastic lesions by colonoscopy with chromoendoscopy using Indigo-carmine versus colonoscopy without chromoendoscopy

Secondary Outcome Measures

Number and rate of targeted and non-targeted biopsies detecting dysplasia and non-dysplasia

Full Information

First Posted
December 29, 2011
Last Updated
March 4, 2019
Sponsor
Karolinska University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01505842
Brief Title
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

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 2011 (undefined)
Primary Completion Date
April 4, 2019 (Anticipated)
Study Completion Date
April 4, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis, Crohn's Colitis
Keywords
Ulcerative colitis, Crohn's disease, Chromoendoscopy, Dysplasia, Neoplasia, Inflammatory Bowel Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
304 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Colonoscopy with chromoendoscopy
Arm Type
Experimental
Arm 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
Arm Title
Conventional colonoscopy
Arm Type
Active Comparator
Arm Description
White light colonoscopy plus 32 random biopsies plus biopsies from suspicious areas
Intervention Type
Procedure
Intervention Name(s)
Colonoscopy with Indigo-Carmine chromoendoscopy
Other Intervention Name(s)
Indigo-Carmine
Intervention 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
Intervention Type
Procedure
Intervention Name(s)
Conventional white-light colonoscopy
Intervention Description
White light colonoscopy plus 32 random biopsies plus biopsies from suspicious areas
Primary Outcome Measure Information:
Title
Prevalence of dysplastic lesions
Description
Number of patients with dysplastic lesions by colonoscopy with chromoendoscopy using Indigo-carmine versus colonoscopy without chromoendoscopy
Time Frame
12 month
Secondary Outcome Measure Information:
Title
Number and rate of targeted and non-targeted biopsies detecting dysplasia and non-dysplasia
Time Frame
12 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter T Schmidt, MD, PhD
Organizational Affiliation
Karolinska University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karoliniska University Hospital, Dept. of Gastroenterology
City
Stockholm
ZIP/Postal Code
17176
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
32353535
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.
Results Reference
derived

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Chromoendoscopy for Dysplasia Detection in Chronic Inflammatory Bowel Disease

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