Upper GI Outcomes Following EMR

NCT ID: NCT02305290

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

2014-08-31

Study Completion Date

2023-09-30

Brief Summary

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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

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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.

Conditions

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Adenoma, Villous

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Endoscopic Mucosal Resection

Patients who are referred for Endoscopic Mucosal Resection of Upper Gastrointestinal 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

* 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
Minimum Eligible Age

18 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 Endoscopy Unit

Westmead, New South Wales, Australia

Site Status

Countries

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Australia

Other Identifiers

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HREC2014/7/4.6 (4033)

Identifier Type: -

Identifier Source: org_study_id

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