Overview
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:
- En bloc resection rate
- Immediate and delayed adverse events
- Procedure time
- Histologic quality of resection (deep and lateral margins)
- Residual disease at resection scar on surveillance endoscopy oMetachronous gastric NETs during follow-up
Description
Study design This is a prospective, single-centre, single-arm cohort study evaluating UEMR for type I gastric NETs. Outcomes will be assessed at the lesion level, with statistical methods accounting for clustering of multiple lesions within individual patients.
Study population Inclusion criteria Patient-level
- Age ≥18 years
- Fit for endoscopic therapy and sedation
- Written informed consent Lesion-level
3.Endoscopically visible gastric neuroendocrine tumor 4.Size 5-9 mm (endoscopic estimation) 5.Clinical and/or histologic features consistent with type I gastric NET 6.No endoscopic features suggestive of deep invasion 7.Technically amenable to snare resection Exclusion criteria
Lesion-level
- Lesions \<5 mm (managed with surveillance in routine practice)
- Lesions ≥10 mm
- Type II or type III gastric NET
- Evidence of muscularis propria invasion on EUS
- Distant metastasis or nodal disease on DOTANOC PET-CT
- Prior attempted resection at the same site with significant fibrosis
- Non-lifting lesion due to scarring
Patient-level
- Uncorrectable coagulopathy
- Inability to manage antithrombotic therapy as per guidelines
- Pregnancy
- Inability to provide informed consent
Pre-procedure evaluation
- Detailed clinical assessment and laboratory work-up as per institutional protocol
- Endoscopic documentation of:
- Lesion size, location, morphology
- Number of lesions
- Background mucosal atrophy
- EUS performed for lesions ≥8 mm, atypical morphology, or suspected deeper invasion
- DOTANOC PET-CT performed where clinically indicated to exclude metastatic disease
Intervention: Underwater EMR technique
- 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
Histopathologic assessment:
All specimens will be evaluated by experienced gastrointestinal pathologists.
Reported parameters:
- Tumor size
- Tumor grade and Ki-67 index
- Depth of invasion
- Lateral and vertical margins
- Lymphovascular invasion
- Resection status classified as:
- R0: negative lateral and vertical margins
- R1: microscopic margin positivity
- Rx: indeterminate margins
Outcome measures Primary outcome
- R0 resection rate per lesion Secondary outcomes
- En bloc resection rate
- Immediate bleeding (requiring endoscopic hemostasis)
- Delayed bleeding (within 14 days requiring medical attention)
- Perforation
- Procedure time (scope insertion to removal)
- Residual disease at scar on surveillance endoscopy (3-6 months)
- Metachronous lesions during follow-up
Follow-up protocol
- Clinical follow-up at 24-72 hours and at 14 days
- Surveillance endoscopy at 3-6 months post-resection
- Further surveillance as per institutional protocol for type I gastric NETs
Eligibility
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


