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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Familial Adenomatous Polyposis

Intervention / Treatment
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* Procedure: Personalized surveillance and intervention protocol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Personalized surveillance and intervention protocol<br> | Procedure: Personalized surveillance and intervention protocol<br>* This study uses one arm. Participants will undergo endoscopic surveillance with intervals between 3-6 months and 5 years, depending on severity of polyposis and performed endoscopic interventions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Advanced neoplasia | Incidence of advanced neoplasia defined as adenomas ≥15mm, high grade dysplasia (HGD) and/or duodenal/ampullary cancer | Up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrences after different endoscopic intervention techniques | 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 | Analysis at 2 years and 5 years | 
| Feasibility of endoscopic interventions | Incidence of lesions not amenable to endoscopic removal | Analysis at 2 years and 5 years | 
| Accuracy optical diagnosis | 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. | Analysis at 2 years and 5 years | 
| Complications | Incidence of endoscopy related complications | Analysis at 2 years and 5 years | 
| Surveillance burden | Surveillance burden (number of endoscopies for each patient) | Up to 5 years | 
| Surgery | Incidence of surgical interventions | Up to 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endoscopic surveillance, Endoscopic interventions, Personalized care, Gastrointestinal neoplasia