Upper GI Outcomes Following EMR

Completed

• Conditions: Adenoma, Villous

• Registration Number: NCT02305290
• Lead Sponsor: Professor Michael Bourke

Brief Summary

The purpose of this study is to evaluate the long-term outcomes of Endoscopic Resection (ER) of superficial lesions of the Upper Gastrointestinal Tract(UGIT)

Detailed Description

Endoscopic resection (ER) of superficial lesions of the upper gastrointestinal tract 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 UGIT.

Study Timeline

• Study First Submitted: 2014-07-30
• Study Start: 2014-08
• Study First Submitted QC: 2014-11-26
• Study First Posted: 2014-12-02
• Primary Completion: 2023-03
• Study Completion: 2023-09
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-27

Recruitment & Eligibility

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

Inclusion Criteria

• UGIT lesion > 10mm
• Lesion limited to the mucosal and/or submucosal layer (T1 lesion)
• Aged 18 years or older

Exclusion Criteria

• Lesion less than 10mm
• Gastric 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

Primary Outcome Measures

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

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 UGIT lesions

Trial Locations

Locations (1)

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