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

NCT ID: NCT01764542

Last Updated: 2016-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2015-02-28

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.

Conditions

Ulcerative Colitis; Dysplasia; Surgery

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Endoscopy and biopsy

Endoscopy with biopsy taken Endoscopy and biopsy Blood samples Questionnaire

Group Type: OTHER

Endoscopy and biopsy

Intervention Type: PROCEDURE

Endoscopy with biopsy of the ileo-anal pouch and the ileo-anal anastomosis Blood samples

Interventions

Endoscopy and biopsy

Endoscopy with biopsy of the ileo-anal pouch and the ileo-anal anastomosis Blood samples

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mattias Block

OTHER

Sponsor Role: lead

Responsible Party

Mattias Block

Doctor, Surgeon, MD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Lars Börjesson, Surgeon

Role: STUDY_CHAIR

Department of Surgery, Sahlgrenska, Göteborg

Locations

Department of Surgery, Inst for Clinical Sciences, Sahlgrenska University Hospital

Gothenburg, Göteborg, Sweden

Countries

Sweden

Other Identifiers

GLS-249941

Identifier Type: -

Identifier Source: org_study_id