A Personalized Surveillance and Intervention Protocol for Duodenal and Gastric Polyposis in Patients With Familial Adenomatous Polyposis
概览
- 阶段
- 不适用
- 干预措施
- Personalized surveillance and intervention protocol
- 疾病 / 适应症
- Familial Adenomatous Polyposis
- 发起方
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- 入组人数
- 1000
- 试验地点
- 2
- 主要终点
- Advanced neoplasia
- 状态
- 招募中
- 最后更新
- 2个月前
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.
研究者
Prof. Evelien Dekker, MD, PhD
Prof. dr. Evelien Dekker, MD, PhD
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
入排标准
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
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)