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

Recruiting

• Conditions: Familial Adenomatous Polyposis
• Interventions: Procedure: Personalized surveillance and intervention protocol

• Registration Number: NCT04677998
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief Summary

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)

Detailed Description

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.

Study Timeline

• Study Start: 2020-11-24
• Study First Submitted: 2020-11-24
• Status Verified: 2020-12
• Study First Submitted QC: 2020-12-16
• Last Update Submitted: 2020-12-16
• Study First Posted: 2020-12-21
• Last Update Posted: 2020-12-21
• Primary Completion: 2025-11
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• 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

Exclusion Criteria

• Endoscopic removal of all polyps with an indication for removal not possible/feasible
• Gastric or duodenal cancer at baseline endoscopy
• Need for surgery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Personalized surveillance and intervention protocol	Personalized surveillance and intervention protocol	-

Primary Outcome Measures

Name	Time	Method
Advanced neoplasia	Up to 5 years	Incidence of advanced neoplasia defined as adenomas ≥15mm, high grade dysplasia (HGD) and/or duodenal/ampullary cancer

Secondary Outcome Measures

Name	Time	Method
Feasibility of endoscopic interventions	Analysis at 2 years and 5 years	Incidence of lesions not amenable to endoscopic removal
Recurrences after different endoscopic intervention techniques	Analysis at 2 years and 5 years	Incidence of recurrences after endoscopic interventions after en bloc/piecemeal resection and different techniques such as cold snare polypectomy or endoscopic mucosal resection with or without lifting
Accuracy optical diagnosis	Analysis at 2 years and 5 years	The ability of endoscopists to optically diagnose duodenal and gastric lesions. Sensitivity and specificity for optically diagnose high-grade dysplasia in the stomach and duodenum.
Complications	Analysis at 2 years and 5 years	Incidence of endoscopy related complications
Surveillance burden	Up to 5 years	Surveillance burden (number of endoscopies for each patient)
Surgery	Up to 5 years	Incidence of surgical interventions

Trial Locations

Locations (1)

Academic Medical Centre; 🇳🇱 Amsterdam, Noord-Holland, Netherlands