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NCT07728292
Safety and Efficacy of Underwater Endoscopic Mucosal Resection for Type I Gastric Neuroendocrine Tumors Measuring 5-9 mm
Conditions: Stomach Neuroendocrine Neoplasm
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: NA
Enrollment: 60
Sponsor: Asian Institute of Gastroenterology, India
Location: Asian Institute of Gastroenterology/AIG Hospitals Hyderabad Telangana
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 Criteria
Inclusion Criteria:
Patient-level
* Age ≥18 years
* Fit for endoscopic therapy and sedation
* Written informed consent
Exclusion Criteria:
Lesion-level
* 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
* Technically amenable to snare resection
Source: ClinicalTrials.gov (NCT07728292). StuddyBuddy aggregates publicly available trial information.
