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