Development of Dysplasia in the Pelvic Pouch in Patients With Ulcerative Colitis (UC) and Risk Factors
The purpose of this study is to study development of dysplasia in the ileal mucosa among patients with Ulcerative Colitis and who previous have hade risk factors for developing cellular changes/dysplasia, i.e. previous dysplasia and/or carcinoma in their specimen.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Critical Assessment of Routine Surveillance of Asymptomatic Patients With Ulcerative Colitis With Ileal Pouch-anal Anastomosis and Risk Factors for Dysplasia - is There a Rationale?|
- Presence of dysplasia in patients with Ulcerative Colitis and Ileal Pouch-Anal Anastomosis [ Time Frame: Up to 7 days ] [ Designated as safety issue: No ]The study ends at above mentioned date. After that, microscopic evaluation, statistics and analysis will be done.
|Study Start Date:||February 2010|
|Estimated Study Completion Date:||November 2013|
|Estimated Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
Active Comparator: Endoscopy and biopsy
Endoscopy with biopsy taken Endoscopy and biopsy Blood samples Questionnaire
Procedure: Endoscopy and biopsy
Endoscopy with biopsy of the ileo-anal pouch and the ileo-anal anastomosis Blood samples
Objective Some of the rare complications reported in patients with an ileal pouch-anal anastomosis (IPAA) after colectomy for chronic ulcerative colitis are dysplasia and carcinoma. The supposed pathway is for the ileal pouch mucosa to go through adaptational changes then to progress through the phases of chronic pouchitis, dysplasia and subsequently to adenocarcinoma. The purpose of this study is to study development of dysplasia in the ileal mucosa among patients with Ulcerative Colitis and who previous have hade risk factors for developing cellular changes/dysplasia, i.e. previous dysplasia and/or carcinoma in their specimen.
Methods In a cohort of 680 patients having IPAA with a median follow-up time of 18 years, 75 patients with risk factors for dysplasia were identified. Sixty-five patients were eligible for inclusion, fifty-six patients accepted to participate in the study. Patients are invited for clinical examination, endoscopy with macroscopic evaluation as well as mucosal biopsies. The biopsies are reviewed and evaluated by two independent pathologists, experienced in colonic pathology, concerning morphological changes, dysplasia and potential carcinoma Results Architectural structural changes, inflammation and reactive atypia is noted in the rectal cuff and ileal pouch. So far, none of the biopsies showed genuine dysplasia after a follow up for 18 years (Range 12-23 years). In this respect there is full agreement between the two pathologists.
Further microscopic evaluation are planned for the rest of the participating patients.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01764542
|Department of Surgery, Inst for Clinical Sciences, Sahlgrenska University Hospital|
|Göteborg, Sweden, 41685|
|Study Chair:||Lars Börjesson, Surgeon||Department of Surgery, Sahlgrenska, Göteborg|