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

April 18, 2016 updated by: Mattias Block

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?

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Göteborg, Sweden, 41685
        • Department of Surgery, Inst for Clinical Sciences, Sahlgrenska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mattias Block

Investigators

  • Study Chair: Lars Börjesson, Surgeon, Department of Surgery, Sahlgrenska, Göteborg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

September 27, 2012

First Submitted That Met QC Criteria

January 7, 2013

First Posted (Estimate)

January 9, 2013

Study Record Updates

Last Update Posted (Estimate)

April 19, 2016

Last Update Submitted That Met QC Criteria

April 18, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GLS-249941

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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