Outcomes of Endoscopic Resection of Mucosal and Submucosal Lesions in the Stomach
Completed
- Conditions
- Adenoma, Villous
- Interventions
- Procedure: Endoscopic Mucosal Resection
- Registration Number
- NCT02306707
- Lead Sponsor
- Professor Michael Bourke
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Endoscopic Mucosal Resection Endoscopic Mucosal Resection Patients who are referred for Endoscopic Mucosal Resection of Stomach Lesions will be included in this cohort.
- Primary Outcome Measures
Name Time Method Observed procedural data: Number of Participants with Adverse Events as a Measure of Safety and Tolerability Outcomes 14 days
- Secondary Outcome Measures
Name Time Method Analysis of the costs of this procedure compared to previous treatments 14 days Perform cost-utility analyses comparing different treatment approaches for stomach lesions
Trial Locations
- Locations (1)
Westmead Hospital Endoscopy Unit
🇦🇺Sydney, New South Wales, Australia