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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Mattias Block, Sahlgrenska University Hospital
ClinicalTrials.gov Identifier:
NCT01764542
First received: September 27, 2012
Last updated: February 19, 2013
Last verified: February 2013
  Purpose

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 Intervention
Ulcerative Colitis
Dysplasia
Surgery
Procedure: Endoscopy and biopsy

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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?

Resource links provided by NLM:


Further study details as provided by Sahlgrenska University Hospital, Sweden:

Primary Outcome Measures:
  • Presence of dysplasia in patients with Ulcerative Colitis and Ileal Pouch-Anal Anastomosis [ Time Frame: Up to 7 days ] [ Designated as safety issue: No ]
    The study ends at above mentioned date. After that, microscopic evaluation, statistics and analysis will be done.


Estimated Enrollment: 56
Study Start Date: February 2010
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Not able to give consent
  • CD (Crohns disease)
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01764542

Locations
Sweden
Department of Surgery, Inst for Clinical Sciences, Sahlgrenska University Hospital
Göteborg, Sweden, 41685
Sponsors and Collaborators
Mattias Block
Investigators
Study Chair: Lars Börjesson, Surgeon Department of Surgery, Sahlgrenska, Göteborg
  More Information

No publications provided

Responsible Party: Mattias Block, Doctor, Surgeon, MD, Sahlgrenska University Hospital
ClinicalTrials.gov Identifier: NCT01764542     History of Changes
Other Study ID Numbers: GLS-249941
Study First Received: September 27, 2012
Last Updated: February 19, 2013
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Sahlgrenska University Hospital, Sweden:
Ulcerative colitis
dysplasia
risk factor
surgery

Additional relevant MeSH terms:
Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases

ClinicalTrials.gov processed this record on September 30, 2014