The Australia and New Zealand Multicentre Upper Gastrointestinal Endoscopic Tissue Resection Study

Recruiting

• Conditions: GI Cancer; GIST; Esophageal Neoplasms; Cancer of Stomach; Gastric Cancer; Gastric Adenocarcinoma; Oesophageal Cancer; Neuroendocrine Tumors; Gastric Neoplasm

• Registration Number: NCT05804331
• Lead Sponsor: Western Sydney Local Health District

Brief Summary

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

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 Timeline

• Study First Submitted: 2023-03-12
• Study Start: 2023-03-14
• Study First Submitted QC: 2023-03-26
• Study First Posted: 2023-04-07
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-27
• Primary Completion: 2028-03-14
• Study Completion: 2028-09-14

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Westmead Hospital; 🇦🇺 Sydney, New South Wales, Australia