About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Patients referred to tertiary centre for endoscopic resection of gastrointestinal neoplasm
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Effectiveness of endoscopic resection of UGI neoplastic lesions: completeness of resection
Determined based on clear margins in histology review
Safety: intra and post procedural; bleeding; perforation; anaesthetic
Intraprocedural bleeding, clinically significant post-polypectomy bleeding, deep mural injury, post polypectomy coagulation syndrome
Long term outcomes: recurrent and residual disease
Determined at subsequent procedures
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
Need for more than one endoscopic therapy
Determined after follow up procedures
Need for surgery
Determined after follow up procedures, histological review
Post ESD, EFTR, STER defect features
Determined after complete resection
Sponsors and contacts
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