Status:
UNKNOWN
Device Assisted Full Thickness Resection Versus Endoscopic Submucosal Dissection for Duodenal Neuroendocrine Tumors
Lead Sponsor:
Asian Institute of Gastroenterology, India
Conditions:
Neuroendocrine Tumors
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Introduction : The incidence of duodenal neuroendocrine tumors (DNETs) is increasing. Endoscopic resection is recommended for the management of small DNETs measuring ≤10 mm. Various endoscopic techni...
Detailed Description
Primary objective: Rate of R0 resection in both the groups Secondary outcomes: 1. Technical success: defined as en-bloc resection of the lesion without any residual lesion endoscopically 2. Procedu...
Eligibility Criteria
Inclusion
- Adult patients (≥18 years) with biopsy proven duodenal neuroendocrine tumors (DNETs)
- Size of the lesion \<15 mm
- Absence of local and distant metastases (EUS and DOTANOC scan)
- Willing to provide informed consent
Exclusion
- Large lesions \>15 mm
- Invasion of muscularis layer and beyond on imaging (EUS)
- Scarring or deformity in duodenum
- Active duodenal ulcer
- History of prior resection
- Coagulopathy
Key Trial Info
Start Date :
November 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 30 2025
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT06121752
Start Date
November 10 2023
End Date
March 30 2025
Last Update
October 15 2024
Active Locations (1)
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1
Asian institute of Gastroenterology
Hyderabad, Telangana, India, 500082