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

NCT ID: NCT05804331

Last Updated: 2025-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-14

Study Completion Date

2028-09-14

Brief Summary

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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

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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

Conditions

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Cancer of Stomach Oesophageal Cancer Gastric Cancer Gastric Adenocarcinoma GI Cancer GIST Neuroendocrine Tumors Gastric Neoplasm Esophageal Neoplasms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Western Sydney Local Health District

OTHER

Sponsor Role lead

Responsible Party

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Professor Michael Bourke

Director of Endoscopy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael Bourke

Role: PRINCIPAL_INVESTIGATOR

WSLHD

Locations

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Westmead Hospital

Sydney, New South Wales, Australia

Site Status RECRUITING

Countries

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Australia

Central Contacts

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Michael Bourke

Role: CONTACT

02 8890 5555

Facility Contacts

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Clarence Kerrison

Role: primary

Other Identifiers

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2022/PID02709

Identifier Type: -

Identifier Source: org_study_id

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