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

Surgery Clinical Trial

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?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01764542
• Other study ID #: GLS-249941
• Status: Completed
• Phase: N/A
• First received: September 27, 2012
• Last updated: April 18, 2016
• Start date: February 2010
• Est. completion date: February 2015

Study information

• Verified date: April 2016
• Source: Sahlgrenska University Hospital, Sweden
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: February 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• UC (Ulcerative Colitis)

• IPAA

• risk factor for dysplasia

Exclusion Criteria:

• Not able to give consent

• CD (Crohns disease)

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Dysplasia
• Surgery
• Ulcer
• Ulcerative Colitis

Intervention

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

Locations

Country	Name	City	State
Sweden	Department of Surgery, Inst for Clinical Sciences, Sahlgrenska University Hospital	Göteborg

Sponsors (1)

Lead Sponsor	Collaborator
Mattias Block

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of dysplasia in patients with Ulcerative Colitis and Ileal Pouch-Anal Anastomosis	The study ends at above mentioned date. After that, microscopic evaluation, statistics and analysis will be done.	Up to 7 days	No