Novel Endoscopic Classification for Duodenal Polyposis in Familial Adenomatous Polyposis A Multicenter Observational Study to Develop and Validate Risk Models

What this Trial Is About

Duodenal cancer is a leading cause of death in people with familial adenomatous polyposis (FAP), but the current Spigelman staging system used to guide treatment has limited ability to predict advanced cancer or pre-cancerous changes. The DRACO study is designed to improve risk assessment by analyzing upper endoscopy results from genetically confirmed FAP patients across multiple centers. This observational study aims to develop and test new risk models that better predict high-grade dysplasia and cancer in the duodenum and ampulla of Vater. The study evaluates a new endoscopic classification called DRACO, which uses baseline esophagogastroduodenoscopy (EGD) findings to estimate the risk of duodenal and ampullary high-grade dysplasia and cancer. Participants are grouped based on whether they developed biopsy-confirmed high-grade dysplasia or adenocarcinoma after their initial EGD and are followed through training, validation, and testing cohorts. The study collects detailed endoscopic data, including the Spigelman classification variables, to support development and validation of these risk models. Participants with confirmed FAP undergo multiple upper gastrointestinal endoscopies with complete documentation of polyp characteristics. The study tracks outcomes over an average of five years, measuring sensitivity, specificity, and accuracy of the DRACO classification in predicting advanced neoplasia. Data on histological grading and follow-up are carefully monitored, excluding those with incomplete data or prior duodenal surgery before baseline. This thorough observation aims to improve early detection and guide timely intervention strategies for FAP-related duodenal cancer.

Duodenal Polyposis Classification in FAP