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临床试验/NCT01764542
NCT01764542已完成不适用

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?

Mattias Block2 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2010年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
56
试验地点
2
主要终点
Presence of dysplasia in patients with Ulcerative Colitis and Ileal Pouch-Anal Anastomosis

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • UC (Ulcerative Colitis)
  • risk factor for dysplasia

排除标准

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

结局指标

主要结局

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

时间窗: Up to 7 days

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

次要结局

未报告次要终点

研究者

发起方
Mattias Block
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mattias Block

Doctor, Surgeon, MD

Sahlgrenska University Hospital, Sweden

研究点 (2)

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