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

NCT02306707 | Completed DMC

• 1 other identifier: HREC2014/5/4.1 (3970)
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Adenoma, Villous

Outcome Measures

Primary Outcomes (1)

• Observed procedural data: Number of Participants with Adverse Events as a Measure of Safety and Tolerability Outcomes

  14 days

Secondary Outcomes (1)

• Analysis of the costs of this procedure compared to previous treatments

  14 days

Study Arms (1)

Endoscopic Mucosal Resection

Patients who are referred for Endoscopic Mucosal Resection of Stomach Lesions will be included in this cohort.

Procedure: Endoscopic Mucosal Resection

Interventions

Endoscopic Mucosal Resection PROCEDURE

Endoscopic Mucosal Resection

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Professor Michael Bourke: lead

Study Sites (1)

Westmead Hospital Endoscopy Unit

Sydney, New South Wales, 2145, Australia

Location

Related Publications (2)

• Wang H, Nguyen M, Gupta S, Sidhu M, Cronin O, O'Sullivan T, Whitfield A, Lee EYT, Burgess NG, Bourke MJ. Long-term outcomes after endoscopic submucosal dissection for relative indication early gastric cancer in nonsurgical candidates. Gastrointest Endosc. 2024 Oct;100(4):647-659. doi: 10.1016/j.gie.2024.03.032. Epub 2024 Apr 3.

  PMID: 38580133 DERIVED

• 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.

  PMID: 31077699 DERIVED

MeSH Terms

Conditions

Adenoma, Villous

Interventions

Endoscopic Mucosal Resection

Condition Hierarchy (Ancestors)

Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Michael J Bourke, MBBS

  Western Sydney Local Health District

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Gastrointestinal Endoscopy

Study Record Dates

• First Submitted: December 1, 2014
• First Posted: December 3, 2014
• Study Start: October 1, 2014
• Primary Completion: March 1, 2023
• Study Completion: September 1, 2023
• Last Updated: March 27, 2025

Record last verified: 2025-03

Locations

AU (1)