Westmead Endoscopy, Westmead hospital, Western Sydney Local Health District
Sydney, New South Wales, Australia
Location status: Recruiting
NCT Number: NCT07781137
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
Interested in participating?
Request Info18 year and older
All sexes
Observational
Sydney, New South Wales, Australia
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: From enrolment to final surveillance endoscopy (generally 5 years after index procedure)
Time frame: From enrolment to final surveillance endoscopy (generally 5 years after index procedure)
Time frame: From enrolment to final surveillance endoscopy (generally 5 years after index procedure)
Time frame: From enrolment to final surveillance endoscopy (generally 5 years after index procedure)
Rate of surgery
Contact information is provided by the study sponsor or research team.
Western Sydney Local Health District
Other
Retrospective Analysis of Long-term Outcomes of Endoscopic Resection of Duodenal and Ampullary Mucosal and Submucosal Lesions
Acronym: DuoP-ER
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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