跳至主要内容
临床试验/NCT04677998
NCT04677998招募中不适用

A Personalized Surveillance and Intervention Protocol for Duodenal and Gastric Polyposis in Patients With Familial Adenomatous Polyposis

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)2 个研究点 分布在 2 个国家目标入组 1,000 人开始时间: 2020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
2
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 personalized surveillance and intervention protocol for duodenal and gastric polyposis in patients with familial adenomatous polyposis (FAP)

详细描述

Patients with FAP are not only at risk of developing colorectal adenomas but also at high risk of developing duodenal adenomas. In 30% to 92% of FAP patients duodenal adenomas are detected, with a lifetime risk approaching 100%. Of these duodenal adenomas, only a small proportion develops into duodenal cancer, with a prevalence of approximately 5-10% in FAP patients.

Endoscopic surveillance is nowadays the standard of care to prevent FAP patients from developing duodenal cancer. The severity of duodenal polyposis is assessed using the Spigelman classification system. This classification is based on the number, size, histology, and grade of dysplasia of the duodenal adenomas, resulting in a score varying from 0-IV, guiding surveillance intervals and treatment.

Concerns are rising on the accuracy of the Spigelman score as predictor for duodenal cancer, especially for ampullary cancer. Over the past years, multiple studies demonstrated limitations of this staging system including the fact that this classification does not adequately predict duodenal/ampullary cancer and does not guide endoscopic or surgical interventions. A clear endoscopic intervention protocol is needed, not only to prevent the development of cancer but also to prevent the need for duodenal surgery, since these surgical procedures are associated with high complication and mortality rates.

With this study, the investigators aim to evaluate a personalized surveillance and intervention protocol for the duodenum and stomach with the goal to prevent the 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)
  • Age 18 years or older

排除标准

  • Endoscopic removal of all polyps with an indication for removal not possible/feasible
  • Gastric or duodenal 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 defined as adenomas ≥15mm, high grade dysplasia (HGD) and/or duodenal/ampullary cancer

次要结局

  • Feasibility of endoscopic interventions(Analysis at 2 years and 5 years)
  • Recurrences after different endoscopic intervention techniques(Analysis at 2 years and 5 years)
  • Accuracy optical diagnosis(Analysis at 2 years and 5 years)
  • Complications(Analysis at 2 years and 5 years)
  • Surveillance burden(Up to 5 years)
  • Surgery(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 (2)

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