Upper GI Outcomes Following EMR

Adenoma, Villous Clinical Trial

— UGI-EMR  

Official title:

Outcomes of Endoscopic Resection in the Upper Gastrointestinal Tract

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02305290
• Other study ID #: HREC2014/7/4.6 (4033)
• Status: Recruiting
• Start date: August 2014
• Est. completion date: December 2025

Study information

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

Clinical Trial Summary

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)

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Adenoma, Villous

Intervention

Procedure:
• Endoscopic Mucosal Resection

Locations

Country	Name	City	State
Australia	Westmead Endoscopy Unit	Westmead	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 UGIT lesions	14 days