The Australia and New Zealand Multicentre Upper Gastrointestinal Endoscopic Tissue Resection Study (ANZ UGI)

March 25, 2025 updated by: Professor Michael Bourke, Western Sydney Local Health District
To determine the long term outcomes of Endoscopic Submucosal Dissection (ESD), Endoscopic Full Thickness Resection (EFTR) and Submucosal-Tunnelling Endoscopic Resection (STER) for upper gastrointestinal neoplastic lesions

Study Overview

Status

Recruiting

Conditions

Detailed Description

To collect prospective observational data on patients undergoing ESD, EFTR or STER for UGI neoplastic lesions

  • Lesion characteristics including histology
  • Procedural outcomes
  • Safety Outcomes
  • Efficacy outcomes

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients referred to tertiary centre for endoscopic resection of gastrointestinal neoplasm

Description

Inclusion Criteria:

  • UGI neoplastic lesions > 10mm

    • Lesions for ESD limited to the mucosal and/or submucosal layer OR
    • Lesions for EFTR limited to the muscularis propria layer OR
    • Lesions for STER limited to the submucosal and/or muscularis propria layer
  • Aged 18 years or older

Exclusion Criteria:

  • Age less than 18
  • Unable to give informed consent
  • Pregnant or lactating patients
  • Patients with bleeding diathesis or who cannot discontinue ADP blockers (e.g. clopidogrel, prasugrel) or antithrombotics (e.g. warfarin, dabigatran) periprocedurally

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patient with Gastrointestinal neoplasm
Pt referred for resection of gastrointestinal neoplasm. Observational data collected from endoscopic submucosal dissection (ESD), submucosal-tunnelling endoscopic resection (STER) or endoscopic full-thickness resection (EFTR) of gastrointestinal neoplasm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness of endoscopic resection of UGI neoplastic lesions: completeness of resection
Time Frame: 2 weeks
Determined based on clear margins in histology review
2 weeks
Safety: intra and post procedural; bleeding; perforation; anaesthetic
Time Frame: 30 day
Intraprocedural bleeding, clinically significant post-polypectomy bleeding, deep mural injury, post polypectomy coagulation syndrome
30 day
Long term outcomes: recurrent and residual disease
Time Frame: 3 years
Determined at subsequent procedures
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endoscopic sessions, procedure time (in minutes) and overall time (in weeks) needed to achieve the primary objectives
Time Frame: 6 months
Determined after follow up procedure to confirm no recurrence
6 months
Need for more than one endoscopic therapy
Time Frame: 3 years
Determined after follow up procedures
3 years
Need for surgery
Time Frame: 2 months
Determined after follow up procedures, histological review
2 months
Post ESD, EFTR, STER defect features
Time Frame: 1 day
Determined after complete resection
1 day
Patient interviews/questionnaires
Time Frame: 3 years
Determined after follow up procedures
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Western Sydney Local Health District

Investigators

  • Principal Investigator: Michael Bourke, WSLHD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 14, 2023

Primary Completion (Estimated)

March 14, 2028

Study Completion (Estimated)

September 14, 2028

Study Registration Dates

First Submitted

March 12, 2023

First Submitted That Met QC Criteria

March 26, 2023

First Posted (Actual)

April 7, 2023

Study Record Updates

Last Update Posted (Actual)

March 27, 2025

Last Update Submitted That Met QC Criteria

March 25, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022/PID02709

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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