About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age greater than 18
Mucosal or submucosal lesion in the duodenum or ampulla with endoscopic resection performed at Westmead hospital Endoscopic resection occurred between January 2010 to March 2025
Disqualifiers
Age less than 18
Trial population
This study will be conducted at a tertiary referral centre specialising in endoscopic therapy in the duodenum and ampulla. Identifying patients: Participants will be sourced through the current electronic documentation system, utilising the following methods: Provation (endoscopic reporting software) key search for key terms related to: * Duodenal polyp(s) * Duodenal lesion * Duodenal SEL * Duodenal submucosal lesion * Duodenal EMR * Duodenal ESD * Papillectomy * Ampullectomy Electronic referral pathway for endoscopic retrograde cholangiopancreatogram (ERCP) at Westmead Hospital for indications showing: * Duodenal polyp(s) * Duodenal lesion * Duodenal EMR * Duodenal ESD * Papillectomy * Ampullectomy
Trial design
Cohort
Retrospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
To evaluate the recurrence rate of endoscopic resection of mucosal and submucosal lesions in the duodenum and papilla
To assess duodenal and ampulla endoscopic resection procedure adverse event rates
To investigate long-term outcomes, including rates of recurrence, residual disease, and malignancy.
Secondary outcomes
Requirements for surgery
Rate of surgery
Sponsors and contacts
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