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

NCT05804331 — Recruiting, 500 participants, Western Sydney Local Health District

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Registry	NCT05804331, acronym ANZ UGI
Status	Recruiting
Study type	Observational
Enrollment	500 (Estimated)
Sponsor	Western Sydney Local Health District (Other)
Conditions	Cancer of Stomach, Oesophageal Cancer, Gastric Cancer, Gastric Adenocarcinoma, GI Cancer, GIST, Neuroendocrine Tumors, Gastric Neoplasm, Esophageal Neoplasms
Dates	start 2023-03-14, primary completion 2028-03-14 (estimated), completion 2028-09-14 (estimated), first posted 2023-04-07, last updated 2025-03-27
Locations	1 site in Australia

-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

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+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

+Arms and interventions

Arm	Type	Interventions	Description
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

+Outcome measures

Primary outcomes

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
Long term outcomes: recurrent and residual disease [3 years]: Determined at subsequent procedures

Secondary outcomes

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
Need for surgery [2 months]: Determined after follow up procedures, histological review
Post ESD, EFTR, STER defect features [1 day]: Determined after complete resection
Patient interviews/questionnaires [3 years]: Determined after follow up procedures

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
Westmead Hospital	Sydney, New South Wales	Australia	Recruiting

+Investigators

Michael Bourke, Principal investigator, WSLHD

My Notes

Public

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