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

NCT ID: NCT02306707

Last Updated: 2025-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-10-31

Study Completion Date

2023-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Adenoma, Villous

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Endoscopic Mucosal Resection

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

Endoscopic Mucosal Resection

Intervention Type PROCEDURE

Interventions

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Endoscopic Mucosal Resection

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Professor Michael Bourke

OTHER

Sponsor Role lead

Responsible Party

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Professor Michael Bourke

Director of Gastrointestinal Endoscopy

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Michael J Bourke, MBBS

Role: PRINCIPAL_INVESTIGATOR

Western Sydney Local Health District

Locations

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Westmead Hospital Endoscopy Unit

Sydney, New South Wales, Australia

Site Status

Countries

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Australia

References

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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.

Reference Type DERIVED
PMID: 38580133 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31077699 (View on PubMed)

Other Identifiers

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HREC2014/5/4.1 (3970)

Identifier Type: -

Identifier Source: org_study_id

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