Ignite Creation Date:
2024-05-06 @ 3:34 PM
Last Modification Date:
2024-10-26 @ 1:52 PM
Study NCT ID:
NCT04677998
Status:
RECRUITING
Last Update Posted:
2020-12-21
First Post:
2020-11-24
Brief Title:
A Personalized Surveillance and Intervention Protocol for Duodenal and Gastric Polyposis in Patients With Familial Adenomatous Polyposis
Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Organization:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Study Overview
Official Title:
A Personalized Surveillance and Intervention Protocol for Duodenal and Gastric Polyposis in Patients With Familial Adenomatous Polyposis
Status:
RECRUITING
Status Verified Date:
2020-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 duodenalampullary 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
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 duodenalampullary 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None