The Australia and New Zealand Multicentre Upper Gastrointestinal Endoscopic Tissue Resection Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Cancer of Stomach, Oesophageal Cancer, Gastric Cancer, Gastric Adenocarcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
Primary outcome measures
- Effectiveness of endoscopic resection of UGI neoplastic lesions: completeness of resection [Time frame: 2 weeks]
- Safety: intra and post procedural; bleeding; perforation; anaesthetic [Time frame: 30 day]
- Long term outcomes: recurrent and residual disease [Time frame: 3 years]
Secondary outcome measures (5)
- Endoscopic sessions, procedure time (in minutes) and overall time (in weeks) needed to achieve the primary objectives [Time frame: 6 months]
- Need for more than one endoscopic therapy [Time frame: 3 years]
- Need for surgery [Time frame: 2 months]
- Post ESD, EFTR, STER defect features [Time frame: 1 day]
- Patient interviews/questionnaires [Time frame: 3 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Australia · 1 center
- Westmead Hospital — Sydney
Identifiers
NCT: NCT05804331 · 2022/PID02709