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

Sponsor

Mattias Block (Other)

Overall Status

Completed

CT.gov ID

NCT01764542

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ulcerative Colitis Dysplasia Surgery	Procedure: Endoscopy and biopsy	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

56 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (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?

Study Start Date :

Feb 1, 2010

Actual Primary Completion Date :

Jan 1, 2015

Actual Study Completion Date :

Feb 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Other: 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

Arm

Intervention/Treatment

Other: 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

Outcome Measures

Primary Outcome Measures

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.