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

Study Overview
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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

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

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

Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patient with Gastrointestinal neoplasm<br>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 | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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