About this trial
Study objectives:
Primary objective:
1.To determine the histologic R0 resection rate of UEMR for type I gastric NETs measuring 5-9 mm.
Secondary objectives:
To evaluate:
1. En bloc resection rate 2. Immediate and delayed adverse events 3. Procedure time 4. Histologic quality of resection (deep and lateral margins) 5. Residual disease at resection scar on surveillance endoscopy oMetachronous gastric NETs during follow-up
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years
Fit for endoscopic therapy and sedation
Written informed consent
Disqualifiers
Endoscopically visible gastric neuroendocrine tumor
Size 5-9 mm (endoscopic estimation)
Clinical and/or histologic features consistent with type I gastric NET
No endoscopic features suggestive of deep invasion
Trial design
Single group
Treatments tested in this trial
Endoscopic mucosal resection under water
Procedure/Surgery* Standard diagnostic gastroscope * Minimal insufflation followed by complete deflation of the gastric lumen * Lumen filled with normal saline to achieve complete submersion of the lesion * Optional marking for flat or ill-defined lesions * Snare capture with a 1-2 mm margin under water * Resection using standardized electrosurgical settings * Defect management (clips or coagulation) at endoscopist discretion * Retrieval of intact specimen * Specimen orientation and pinning on cork for histopathologic assessment
Treatment groups
Trial outcomes
Primary outcomes
• To determine the histologic R0 resection rate of UEMR for type I gastric NETs measuring 5-9 mm.
No recurrence after 3 months of procedure
Secondary outcomes
Immediate and delayed adverse events
To check any possible adverse events post procedure
Procedure time
To calculate the exact time of procedure
Histologic quality of resection (deep and lateral margins)
To check the depth of invasion of the tumour
Sponsors and contacts
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