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临床试验/NCT04678011
NCT04678011招募中不适用

A Personalized Surveillance and Intervention Protocol for Patients With Familial Adenomatous Polyposis That Have Undergone (Procto)Colectomy

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)3 个研究点 分布在 2 个国家目标入组 1,000 人开始时间: 2021年11月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
1,000
试验地点
3
主要终点
Advanced neoplasia

研究概览

简要总结

The purpose of this study is to determine the efficacy and safety of a personalised surveillance and intervention protocol for patients with familial adenomatous polyposis (FAP) that have undergone (procto)colectomy.

详细描述

Familial adenomatous polyposis (FAP) is characterized by formation of up to hundreds to thousands of polyps throughout the entire colon and rectum. When left untreated, nearly all patients with FAP develop colorectal cancer at a median age of 35-45 years. To prevent colorectal cancer in patients with FAP, prophylactic colorectal surgery is performed. The preferred surgical procedures for FAP are a restorative proctocolectomy with ileal pouch-anal anastomosis (IPAA) or a subtotal colectomy with ileorectal anastomosis (IRA) or ileosigmoidal anastomosis (ISA).

After both types of prophylactic colorectal surgery, subtotal colectomy with IRA/ISA or proctocolectomy with IPAA, patients will require life-long surveillance because disease progression and development of new adenomas in retained rectum, pouch or residual rectal cuff will occur.

The 10-years risk of developing one or more adenomas in the rectum after IRA is 100% compared to 33% in the pouch after IPAA. The risk of developing rectal cancer after IRA was found to be 9% and 11% in two large studies with a median follow-up of 12.8 and 15 years, respectively. One study showed that the 10-years risk of developing a carcinoma in the pouch was 1%. As patients are usually operated at a young age, and nowadays have a long life-expectancy, the actual cumulative life-time risk will presumably be higher.

The recently published ESGE (European Society of Gastrointestinal Endoscopy) polyposis guideline recommends a one to two yearly endoscopic surveillance interval after prophylactic colorectal surgery in FAP, both for patients that underwent IRA/ISA and IPAA, with removal of all polyps >5mm. This recommendation is based on expert-opinion, since no studies have been reported comparing the efficacy and safety of different surveillance intervals. No advices are provided on which patients will benefit from which surveillance interval.

With the proposed study, the investigators aim to provide evidence for personalized endoscopic surveillance for patients with FAP that have undergone (procto)colectomy with construction of an IRA/ISA or IPAA with the goal to prevent development of advanced neoplasia (AN) by endoscopically removing lesions before they progress to AN.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of FAP, at least one of following: genetic diagnosis (proven APC germline mutation) and/or clinical diagnosis (>100 colorectal adenomas in combination with a positive family history of FAP)
  • Have undergone prophylactic (procto)colectomy with IRA/ISA or IPAA
  • Age 18 years or older

排除标准

  • Not able to remove all polyps with an indication for removal during (multiple) clearing endoscopies
  • Cancer at baseline endoscopy
  • Need for surgery

研究组 & 干预措施

Personalized surveillance and intervention protocol

干预措施: Personalized surveillance and intervention protocol (Procedure)

结局指标

主要结局

Advanced neoplasia

时间窗: Up to 5 years

Incidence of advanced neoplasia (advanced adenoma and cancer). An advanced adenoma is defined as size ≥ 10mm and/or high-grade dysplasia. This surveillance and intervention protocol will be considered successful when the incidence of advanced neoplasia is less than 5% after a study period of 5 years.

次要结局

  • Feasibility endoscopic interventions(Up to 5 years)
  • Complications(Up to 5 years)
  • Characteristics polyps(Up to 5 years)
  • Surgical interventions(Up to 5 years)
  • Surveillance burden(Up to 5 years)
  • Radicality of different endoscopic intervention techniques(Up to 5 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Evelien Dekker, MD, PhD

Prof. dr. Evelien Dekker, MD, PhD

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

研究点 (3)

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