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

Recruiting

• Conditions: Adenoma, Villous
• Interventions: Procedure: Endoscopic Mucosal Resection

• Registration Number: NCT02306603
• Lead Sponsor: Professor Michael Bourke

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 Description

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.

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-12-01
• Study First Submitted QC: 2014-12-02
• Study First Posted: 2014-12-03
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-27
• Primary Completion: 2026-10
• Study Completion: 2027-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

* Duodenal and ampullary lesion > 10mm

• Lesion limited to the mucosal and/or submucosal layer (T1 lesion)
• Aged 18 years or older

Exclusion Criteria

• Lesion less than 10mm
• Duodenal or ampullary lesion involves the muscularis propria (T2 lesion) on other staging modalities such as endoscopic ultrasonography (EUS)
• Aged younger than 18 years

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Endoscopic Mucosal Resection	Endoscopic Mucosal Resection	Patients who are referred for Endoscopic Mucosal Resection of Duodenal and Ampullary Lesions will be included in this cohort.

Primary Outcome Measures

Name	Time	Method
Observed procedural data: Number of Participants with Adverse Events as a Measure of Safety and Tolerability Outcomes	14 days

Secondary Outcome Measures

Name	Time	Method
Analysis of the costs of this procedure compared to previous treatments	14 days	Perform cost-utility analyses comparing different treatment approaches for duodenal and ampullary lesions

Trial Locations

Locations (1)

Westmead Hospital Endoscopy Unit; 🇦🇺 Sydney, New South Wales, Australia