Chromoendoscopy for Dysplasia Detection in Chronic Inflammatory Bowel Disease
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Ulcerative Colitis Crohn's Colitis |
Procedure: Colonoscopy with Indigo-Carmine chromoendoscopy Procedure: Conventional white-light colonoscopy |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic |
| 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. |
- Prevalence of dysplastic lesions [ Time Frame: 12 month ] [ Designated as safety issue: No ]Number of patients with dysplastic lesions by colonoscopy with chromoendoscopy using Indigo-carmine versus colonoscopy without chromoendoscopy
- Number and rate of targeted and non-targeted biopsies detecting dysplasia and non-dysplasia [ Time Frame: 12 month ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 300 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | April 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Colonoscopy with 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
|
Procedure: 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
Other Name: Indigo-Carmine
|
|
Active Comparator: Conventional colonoscopy
White light colonoscopy plus 32 random biopsies plus biopsies from suspicious areas
|
Procedure: Conventional white-light colonoscopy
White light colonoscopy plus 32 random biopsies plus biopsies from suspicious areas
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts 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)
Contacts and Locations| Contact: Peter T Schmidt, MD, PhD | +46 8 51770000 | petthe@ki.se |
| Sweden | |
| Karoliniska University Hospital, Dept. of Gastroenterology | Recruiting |
| Stockholm, Sweden, 17176 | |
| Principal Investigator: Peter T Schmidt, MD, PhD | |
| Principal Investigator: | Peter T Schmidt, MD, PhD | Karolinska University Hospital |
More Information
No publications provided
| Responsible Party: | Peter Thelin Schmidt, Head of Endoscopy, Karolinska University Hospital |
| ClinicalTrials.gov Identifier: | NCT01505842 History of Changes |
| Other Study ID Numbers: | PTS-01 |
| Study First Received: | December 29, 2011 |
| Last Updated: | January 4, 2012 |
| Health Authority: | Sweden: Regional Ethical Review Board |
Keywords provided by Karolinska University Hospital:
|
Ulcerative colitis Crohn's disease Chromoendoscopy |
Dysplasia Neoplasia Inflammatory Bowel Disease |
Additional relevant MeSH terms:
|
Colitis Colitis, Ulcerative Crohn Disease Inflammatory Bowel Diseases Ulcer Gastroenteritis |
Gastrointestinal Diseases Digestive System Diseases Colonic Diseases Intestinal Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on June 17, 2013