Clinical Trial: Long-term Outcomes of Endoscopic Resection (ER) of Lesions of the Duodenum and Ampulla

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Outcomes of Endoscopic Resection of Mucosal and Submucosal Lesions in the Duodenum and Ampulla

Brief Summary: This research project, 'Outcomes of endoscopic resection of mucosal and submucosal lesions in the duodenum and ampulla'. The research project is aiming to determine the most effective and safe way to remove such lesions.

Detailed Summary: Endoscopic resection (ER) of superficial lesions of the duodenum and ampulla is a safe and effective surgery sparing modality in experienced hands. It is often curative of dysplastic lesions and is associated with minimal complications and high patient acceptance (1-5). Westmead Hospital has accumulated a significant amount of experience in the removal of such lesions; however, there is limited research to document the long term outcomes of patients undergoing endoscopic resection.The purpose of this study is to evaluate the long-term outcomes of ER of superficial lesions of the duodenum and ampulla.
Sponsor: Professor Michael Bourke

Current Primary Outcome: Observed procedural data: Number of Participants with Adverse Events as a Measure of Safety and Tolerability Outcomes [ Time Frame: 14 days ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Analysis of the costs of this procedure compared to previous treatments [ Time Frame: 14 days ]

Perform cost-utility analyses comparing different treatment approaches for duodenal and ampullary lesions


Original Secondary Outcome: Same as current

Information By: Western Sydney Local Health District

Dates:
Date Received: December 1, 2014
Date Started: October 2014
Date Completion: October 2019
Last Updated: December 15, 2015
Last Verified: December 2015