A Personalized Surveillance and Intervention Protocol for Duodenal and Gastric Polyposis in Patients With Familial Adenomatous Polyposis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Personalized surveillance and intervention protocol.
- Who it may be relevant to
- Registry conditions: Familial Adenomatous Polyposis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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.
Primary outcome measures
- Advanced neoplasia [Time frame: Up to 5 years]
Secondary outcome measures (6)
- Recurrences after different endoscopic intervention techniques [Time frame: Analysis at 2 years and 5 years]
- Feasibility of endoscopic interventions [Time frame: Analysis at 2 years and 5 years]
- Accuracy optical diagnosis [Time frame: Analysis at 2 years and 5 years]
- Complications [Time frame: Analysis at 2 years and 5 years]
- Surveillance burden [Time frame: Up to 5 years]
- Surgery [Time frame: Up to 5 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- MD Anderson — Houston
Netherlands · 1 center
- Academic Medical Centre — Amsterdam
Identifiers
NCT: NCT04677998 · W20_181