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

Last updated: February 20, 2026
Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Overall Status: Active - Recruiting

Phase

N/A

Condition

Colorectal Cancer

Colon Cancer

Colon Polyps

Treatment

Personalized surveillance and intervention protocol

Clinical Study ID

NCT04677998
W20_181
  • Ages > 18
  • All Genders

Study 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)

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of FAP, at least one of following: genetic diagnosis (proven APC germlinemutation) and/or clinical diagnosis (>100 colorectal adenomas in combination with apositive family history of FAP)

  • Age 18 years or older

Exclusion

Exclusion Criteria:

  • Endoscopic removal of all polyps with an indication for removal notpossible/feasible

  • Gastric or duodenal cancer at baseline endoscopy

  • Need for surgery

Study Design

Total Participants: 1000
Treatment Group(s): 1
Primary Treatment: Personalized surveillance and intervention protocol
Phase:
Study Start date:
November 24, 2020
Estimated Completion Date:
November 30, 2027

Study 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.

Connect with a study center

  • Academic Medical Centre

    Amsterdam, Noord-Holland 1105AZ
    Netherlands

    Site Not Available

  • Academic Medical Centre

    Amsterdam 2759794, North Holland 2749879 1105AZ
    Netherlands

    Active - Recruiting

  • MD Anderson

    Houston 4699066, Texas 4736286 77030
    United States

    Active - Recruiting

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