Upper GI Outcomes Following EMR

Professor Michael Bourke200 enrolled

Overview

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)

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 Type

OBSERVATIONAL

Enrollment

200

Conditions

Adenoma, Villous

Interventions

Endoscopic Mucosal ResectionPROCEDURE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Westmead Endoscopy Unit

Westmead, New South Wales, Australia

Outcomes

Primary Outcomes

Observed procedural data

Number of Participants with Adverse Events as a Measure of Safety and Tolerability Outcomes

Time frame: 14 days

Secondary Outcomes

Analysis of the costs of this procedure compared to previous treatments

Perform cost-utility analyses comparing different treatment approaches for UGIT lesions

Time frame: 14 days

Data from ClinicalTrials.gov

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