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OpenTrials
Completed

NCT Number: NCT01764542

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Gothenburg, Göteborg, 41685, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Endoscopy and biopsy

Procedure

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Mattias Block

Other

Registry information

Official study 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?

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Jan 9, 2013
Registry last updated
Apr 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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