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

Adenoma, Villous Clinical Trial

— OERS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02306707
• Other study ID #: HREC2014/5/4.1 (3970)
• Status: Recruiting
• Start date: October 2014
• Est. completion date: April 2027

Study information

• Verified date: June 2023
• Source: Western Sydney Local Health District
• Contact: Kathleen Goodrick, BN
• Phone: 98455555
• Email: Kathleen.goodrick[@]health.nsw.gov.au
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: April 2027
• Est. primary completion date: October 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Adenoma, Villous

Intervention

Procedure:
• Endoscopic Mucosal Resection

Locations

Country	Name	City	State
Australia	Westmead Hospital Endoscopy Unit	Sydney	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Professor Michael Bourke

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Observed procedural data: Number of Participants with Adverse Events as a Measure of Safety and Tolerability Outcomes		14 days
Secondary	Analysis of the costs of this procedure compared to previous treatments	Perform cost-utility analyses comparing different treatment approaches for stomach lesions	14 days