Development of Dysplasia in the Pelvic Pouch in Patients With Ulcerative Colitis (UC) and Risk Factors

Not Applicable

Completed

• Conditions: Ulcerative Colitis; Dysplasia; Surgery
• Interventions: Procedure: Endoscopy and biopsy

• Registration Number: NCT01764542
• Lead Sponsor: Mattias Block

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2012-09-27
• Study First Submitted QC: 2013-01-07
• Study First Posted: 2013-01-09
• Primary Completion: 2015-01
• Study Completion: 2015-02
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-18
• Last Update Posted: 2016-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• UC (Ulcerative Colitis)
• IPAA
• risk factor for dysplasia

Exclusion Criteria

• Not able to give consent
• CD (Crohns disease)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Endoscopy and biopsy	Endoscopy and biopsy	Endoscopy with biopsy taken Endoscopy and biopsy Blood samples Questionnaire

Primary Outcome Measures

Name	Time	Method
Presence of dysplasia in patients with Ulcerative Colitis and Ileal Pouch-Anal Anastomosis	Up to 7 days	The study ends at above mentioned date. After that, microscopic evaluation, statistics and analysis will be done.

Trial Locations

Locations (1)

Department of Surgery, Inst for Clinical Sciences, Sahlgrenska University Hospital; 🇸🇪 Göteborg, Sweden