Clinical trial NCT01764542: 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
Overall status: COMPLETED
Phase: NA
Conditions: Ulcerative Colitis
Dysplasia
Surgery
Keywords: Ulcerative colitis
dysplasia
risk factor
surgery
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2013-01-09
Enrollment: 56
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Presence of dysplasia in patients with Ulcerative Colitis and Ileal Pouch-Anal Anastomosis
timeFrame: Up to 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Göteborg
country: Sweden
facility: Department of Surgery, Inst for Clinical Sciences, Sahlgrenska University Hospital
Study officials:
affiliation: Department of Surgery, Sahlgrenska, Göteborg
name: Lars Börjesson, Surgeon
role: STUDY_CHAIR
References: