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RECRUITING
NCT07781137

Analysis of Long-term Outcomes of Endoscopic Resection of Duodenal and Ampullary Mucosal and Submucosal Lesions

Sponsor: Western Sydney Local Health District

View on ClinicalTrials.gov

Summary

Mucosal and submucosal lesions of the duodenum represent a diverse group of pathologies, ranging from benign adenomas to lesions with significant malignant potential. Endoscopic resection has emerged as a minimally invasive approach; however, the success rates, recurrence patterns, and long-term outcomes remain poorly defined due to the heterogeneity of these lesions. This study aims to retrospectively evaluate the endoscopic management and long-term outcomes of patients who underwent endoscopic resection of mucosal and submucosal lesions in the duodenum and ampulla over a 15-year period. The investigators aim to assess key procedural outcomes, including complete resection rates, recurrence, complication rates, recurrence and morbidity and mortality of duodenal or ampullary malignancy. By analysing these factors, the investigators hope to better understand the role of endoscopic therapy in managing these challenging lesions and identify predictors of long-term success. This data will help guide future practice and optimize surveillance strategies for patients undergoing endoscopic resection in this complex anatomical region. Primary Objective 1. To evaluate the effectiveness of endoscopic resection of mucosal and submucosal lesions (MSML) in the duodenum and ampulla. 2. To assess the safety profile of the procedure. 3. To investigate long-term outcomes, including rates of recurrence, residual disease, and malignancy. Secondary Objectives 1. Diagnostic yield of endoscopic surveillance post endoscopic resection 2. Requirements for surgery

Official title: Retrospective Analysis of Long-term Outcomes of Endoscopic Resection of Duodenal and Ampullary Mucosal and Submucosal Lesions

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

1000

Start Date

2025-05-23

Completion Date

2030-01

Last Updated

2026-08-24

Healthy Volunteers

No

Locations (1)

Westmead Endoscopy, Westmead hospital, Western Sydney Local Health District

Sydney, New South Wales, Australia