Outcomes of Endoscopic Resection of Mucosal and Submucosal Lesions in the Stomach (OERS)

Outcomes of Endoscopic Resection of Mucosal and Submucosal Lesions in the Stomach.

A patient referred to have a lesion in the stomach removed. The aims of this study are to collect information on the technique of endoscopic removal of such lesions. By collecting information on a large number of patients undergoing this procedure the investigators can determine the best ways of diagnosing and removing these lesions safely and effectively.

Study Overview

• Status: Recruiting
• Conditions: Adenoma, Villous
• Intervention / Treatment: Procedure: Endoscopic Mucosal Resection

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Kathleen Goodrick, BN; Phone Number: 59779 98455555; Email: kathleen.goodrick@health.nsw.gov.au
• Study Contact Backup: Name: Farzan F Bahin, MBBS; Phone Number: 56700 98455555; Email: farzan.fahrtash@sydney.edu.au

Study Locations

• Australia
  • New South Wales
    • Sydney, New South Wales, Australia, 2145
      • Recruiting
      • Westmead Hospital Endoscopy Unit
      • Contact: Kathleen Goodrick, BN; Phone Number: 59779 98455555; Email: kathleen.goodrick@health.nsw.gov.au
      • Contact: Michael J Bourke, BN; Phone Number: 56700 98455555; Email: westmeadendoscopyresearch@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who have stomach adenomas which are amendable to Endoscopic Mucosal Resection

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Endoscopic Mucosal Resection; Patients who are referred for Endoscopic Mucosal Resection of Stomach Lesions will be included in this cohort.	Procedure: Endoscopic Mucosal Resection

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analysis of the costs of this procedure compared to previous treatments	Perform cost-utility analyses comparing different treatment approaches for stomach lesions	14 days

Collaborators and Investigators

• Sponsor: Professor Michael Bourke
• Investigators: Principal Investigator: Michael J Bourke, MBBS, Western Sydney Local Health District

Publications and helpful links

General Publications

• Tate DJ, Klein A, Sidhu M, Desomer L, Awadie H, Lee EYT, Mahajan H, McLeod D, Bourke MJ. Endoscopic submucosal dissection for suspected early gastric cancer: absolute versus expanded criteria in a large Western cohort (with video). Gastrointest Endosc. 2019 Sep;90(3):467-479.e4. doi: 10.1016/j.gie.2019.04.242. Epub 2019 May 8.

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: December 1, 2014
• First Submitted That Met QC Criteria: December 2, 2014
• First Posted (Estimated): December 3, 2014

Study Record Updates

• Last Update Posted (Actual): June 29, 2023
• Last Update Submitted That Met QC Criteria: June 28, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Adenoma; Adenoma, Villous
• Other Study ID Numbers: HREC2014/5/4.1 (3970)