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

Western Sydney Local Health District500 enrolled

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

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 Type

OBSERVATIONAL

Enrollment

500

Conditions

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Effectiveness of endoscopic resection of UGI neoplastic lesions: completeness of resection

Determined based on clear margins in histology review

Time frame: 2 weeks

Safety: intra and post procedural; bleeding; perforation; anaesthetic

Intraprocedural bleeding, clinically significant post-polypectomy bleeding, deep mural injury, post polypectomy coagulation syndrome

Time frame: 30 day

Long term outcomes: recurrent and residual disease

Determined at subsequent procedures

Time frame: 3 years

Secondary Outcomes

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

Time frame: 6 months

Need for more than one endoscopic therapy

Determined after follow up procedures

Time frame: 3 years

Need for surgery

Determined after follow up procedures, histological review

Time frame: 2 months

Post ESD, EFTR, STER defect features

Determined after complete resection

Time frame: 1 day

Patient interviews/questionnaires

Determined after follow up procedures

Time frame: 3 years

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

Overview

Conditions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts