UGI-EMR: Upper GI Outcomes Following EMR

• Sponsor: Professor Michael Bourke (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT02305290
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Anticipated Duration (Months): 100
• Patients Per Site Per Month: 2

Study Details

Study Description

Brief 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)

Condition or Disease	Intervention/Treatment	Phase
Adenoma, Villous	Procedure: Endoscopic Mucosal Resection

Detailed 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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 200 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Outcomes of Endoscopic Resection in the Upper Gastrointestinal Tract
• Actual Study Start Date: Aug 1, 2014
• Anticipated Primary Completion Date: Dec 1, 2021
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Endoscopic Mucosal Resection Patients who are referred for Endoscopic Mucosal Resection of Upper Gastrointestinal Lesions will be included in this cohort.	Procedure: Endoscopic Mucosal Resection

Outcome Measures

Primary Outcome Measures

1. Observed procedural data [14 days]

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

Secondary Outcome Measures

1. Analysis of the costs of this procedure compared to previous treatments [14 days]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Westmead Endoscopy Unit	Westmead	New South Wales	Australia	2145

Sponsors and Collaborators

• Professor Michael Bourke

Investigators

• Principal Investigator: Michael J Bourke, MBBS, Western Sydney Local Health District

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Professor Michael Bourke, Director of Gastrointestinal Endoscopy, Western Sydney Local Health District
• ClinicalTrials.gov Identifier: NCT02305290
• Other Study ID Numbers: HREC2014/7/4.6 (4033)
• First Posted: Dec 2, 2014
• Last Update Posted: Mar 24, 2021
• Last Verified: Mar 1, 2021

• Additional relevant MeSH terms: Adenoma; Adenoma, Villous

Study Results

No Results Posted as of Mar 24, 2021