Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07781137 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

Study acronym: DuoP-ER
StatusRecruiting
PhaseNot specified
Started2025-05-23
View on ClinicalTrials.gov ↗
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
Trial Details
NCT Number NCT07781137
Lead Sponsor Western Sydney Local Health District
Conditions Duodenal Adenoma, Duodenal Carcinoma, Papillary Adenoma, Papillary Adenocarcinoma, Endoscopic Mucosal Resection
Enrollment 1,000 participants
Start Date 2025-05-23
Primary Completion 2030-01 (estimated)
Study Completion 2030-01 (estimated)
Updated on ClinicalTrials.gov 2026-08-24