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

Primary Purpose

Ulcerative Colitis, Dysplasia, Surgery

Status

Completed

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Endoscopy and biopsy

About this trial

This is an interventional prevention trial for Ulcerative Colitis focused on measuring Ulcerative colitis, dysplasia, risk factor, surgery

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

UC (Ulcerative Colitis)
IPAA
risk factor for dysplasia

Exclusion Criteria:

Not able to give consent
CD (Crohns disease)

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Endoscopy and biopsy

Arm Description

Endoscopy with biopsy taken Endoscopy and biopsy Blood samples Questionnaire

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01764542

First Posted

September 27, 2012

Last Updated

April 18, 2016

Sponsor

Mattias Block

1. Study Identification

Unique Protocol Identification Number

NCT01764542

Brief Title

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

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?

Study Type

Interventional

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Completed

Study Start Date

February 2010 (undefined)

Primary Completion Date

January 2015 (Actual)

Study Completion Date

February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Mattias Block

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ulcerative Colitis, Dysplasia, Surgery

Keywords

Ulcerative colitis, dysplasia, risk factor, surgery

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

56 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Endoscopy and biopsy

Arm Type

Other

Arm Description

Endoscopy with biopsy taken Endoscopy and biopsy Blood samples Questionnaire

Intervention Type

Procedure

Intervention Name(s)

Endoscopy and biopsy

Intervention Description

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

Primary Outcome Measure Information:

Title

Presence of dysplasia in patients with Ulcerative Colitis and Ileal Pouch-Anal Anastomosis

Description

The study ends at above mentioned date. After that, microscopic evaluation, statistics and analysis will be done.

Time Frame

Up to 7 days

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: UC (Ulcerative Colitis) IPAA risk factor for dysplasia Exclusion Criteria: Not able to give consent CD (Crohns disease)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lars Börjesson, Surgeon

Organizational Affiliation

Department of Surgery, Sahlgrenska, Göteborg

Official's Role

Study Chair

Facility Information:

Facility Name

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

City

Göteborg

ZIP/Postal Code

41685

Country

Sweden

12. IPD Sharing Statement

Learn more about this trial

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

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