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

February 20, 2026 updated by: Prof. Evelien Dekker, MD, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • North Holland
      • Amsterdam, North Holland, Netherlands, 1105AZ
        • Recruiting
        • Academic Medical Centre
        • Contact:
        • Sub-Investigator:
          • Arthur Aelvoet, MD
  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • MD Anderson
        • Contact:
        • Principal Investigator:
          • Luigi Ricciardiello

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with FAP treated at one of the participating centers will be assessed for eligibility.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Personalized surveillance and intervention protocol
Procedure: Personalized surveillance and intervention protocol
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

M.D. Anderson Cancer Center
Radboud University Medical Center
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Hospital Clinic of Barcelona
Hvidovre University Hospital
St Mark's Hospital Foundation
University Hospital, Bonn
The Netherlands Cancer Institute
Leiden University Medical Center
Maria Sklodowska-Curie National Research Institute of Oncology
Hospital General Universitario de Alicante

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 24, 2020

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2027

Study Registration Dates

First Submitted

November 24, 2020

First Submitted That Met QC Criteria

December 16, 2020

First Posted (Actual)

December 21, 2020

Study Record Updates

Last Update Posted (Actual)

February 23, 2026

Last Update Submitted That Met QC Criteria

February 20, 2026

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • W20_181

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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