Actively Recruiting
The Australia and New Zealand Multicentre Upper Gastrointestinal Endoscopic Tissue Resection Study
Led by Western Sydney Local Health District · Updated on 2025-03-27
500
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are collecting long-term data on patients undergoing different endoscopic procedures—Endoscopic Submucosal Dissection (ESD), Endoscopic Full Thickness Resection (EFTR), and Submucosal-Tunnelling Endoscopic Resection (STER)—to treat upper gastrointestinal (UGI) neoplastic lesions. The study aims to evaluate lesion characteristics, procedural outcomes, safety, and effectiveness in removing these lesions. It is an observational study sponsored by the Western Sydney Local Health District. Patients referred for resection of gastrointestinal neoplasms will undergo one of the endoscopic procedures (ESD, EFTR, or STER). Observational data will be collected on the lesion's histology, the completeness of resection, safety events such as bleeding or perforation, and long-term outcomes including recurrence or residual disease. The study will monitor outcomes at various time points ranging from 1 day to 3 years after the procedures. Participants will be monitored through clinical assessments, patient interviews, questionnaires, and procedural data collection. Primary outcomes include the completeness of lesion resection within 2 weeks, safety within 30 days, and long-term disease status over 3 years. Secondary outcomes include procedure times, need for additional therapies or surgery, and detailed defect features post-procedure. The total follow-up duration can extend up to 3 years to fully understand long-term effects and safety.
CONDITIONS
Brief Title
The Australia and New Zealand Multicentre Upper Gastrointestinal Endoscopic Tissue Resection Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Upper gastrointestinal neoplastic lesions larger than 10mm
- Lesions for ESD limited to the mucosal and/or submucosal layer
- Lesions for EFTR limited to the muscularis propria layer
- Lesions for STER limited to the submucosal and/or muscularis propria layer
- Aged 18 years or older
You will not qualify if you...
- Age less than 18
- Unable to give informed consent
- Pregnant or lactating patients
- Patients with bleeding diathesis or who cannot discontinue ADP blockers or antithrombotics periprocedurally
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months
Participants undergo endoscopic procedures including ESD, EFTR, or STER to resect upper gastrointestinal neoplastic lesions while observational data are collected.
Multiple endoscopic sessions as needed
Duration - Up to 3 years
Participants are followed to monitor safety outcomes, recurrence of disease, and to complete patient interviews and questionnaires.
Periodic visits over 3 years
Trial Site Locations
Total: 1 location
1
Westmead Hospital
Sydney, New South Wales, Australia, 2145
Actively Recruiting
Research Team
M
Michael Bourke
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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