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

Familial Adenomatous Polyposis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04677998
• Other study ID #: W20_181
• Status: Recruiting
• Start date: November 24, 2020
• Est. completion date: November 2025

Study information

• Verified date: December 2020
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: November 2025
• Est. primary completion date: November 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenomatous Polyposis Coli
• Colorectal Neoplasms
• Familial Adenomatous Polyposis
• Nasopharyngeal Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Academic Medical Centre	Amsterdam	Noord-Holland

Sponsors (10)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	Hôpital Edouard Herriot, Hospital Clinic of Barcelona, Hospital General Universitario de Alicante, Leiden University Medical Center, Maria Sklodowska-Curie Institute - Oncology Center, St Mark's Hospital Foundation, St. Orsola Hospital, The Netherlands Cancer Institute, University Medical Center Mainz

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Advanced neoplasia	Incidence of advanced neoplasia defined as adenomas =15mm, high grade dysplasia (HGD) and/or duodenal/ampullary cancer	Up to 5 years
Secondary	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
Secondary	Feasibility of endoscopic interventions	Incidence of lesions not amenable to endoscopic removal	Analysis at 2 years and 5 years
Secondary	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
Secondary	Complications	Incidence of endoscopy related complications	Analysis at 2 years and 5 years
Secondary	Surveillance burden	Surveillance burden (number of endoscopies for each patient)	Up to 5 years
Secondary	Surgery	Incidence of surgical interventions	Up to 5 years