Safety and Efficacy of Underwater Endoscopic Mucosal Resection for Type I Gastric Neuroendocrine Tumors Measuring 5-9 mm

Condition(s) studied

Investigational drug(s) / intervention(s)

Endoscopic mucosal resection under water: * 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

Study summary

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

Primary outcome measure(s)

• • To determine the histologic R0 resection rate of UEMR for type I gastric NETs measuring 5-9 mm. — 3 months
  No recurrence after 3 months of procedure

Trial sites (1)

More Asian Institute of Gastroenterology, India trials in India