Overview
The goal of this muticentre randomized controlled trial is to compare endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) with surgery for treatment of pancreatic insulinoma. The main questions it aims to answer are: 1) What is the safest treatment? 2) Is efficacy comparable? Patients will be randomized to undergo EUS-RFA or surgical resection. Researchers will compare the rate of adverse events and the clinical efficacy after the two treatments to see if EUS-RFA result safer and effective compare with surgery.
Eligibility
Inclusion Criteria:
- Age ≥18 years
- Diagnosis of pancreatic insulinoma (38) (e.g., fasting test, insulin blood levels, C-peptide blood levels)
- Presence of a visible single pancreatic nodule on imaging (computed tomography, and/or magnetic resonance imaging, and/or endoscopic ultrasound).
- No evidence of distant localizations visualized at computed tomography, and/or magnetic resonance imaging, and/or endoscopic ultrasound
- Tumor ≤ 2cm
- Informed consent provided by the patient or closest relative.
Exclusion Criteria:
- G2 with Ki-67 >5% on histological examination at EUS-guided biopsy samples (if performed)
- Distance between lesion and main pancreatic duct ≤ 1mm or upstream dilation of the main pancreatic duct
- Metastatic tumor at the time of diagnosis
- Multiple pancreatic nodules
- Diagnosis of multiple endocrine neoplasia type 1 according to guidelines
- Unfit for surgery or high-risk surgical patients
- Endoscopic ultrasound not feasible for surgical altered anatomy
- Known bleeding disorder that cannot be sufficiently corrected with co-fact or fresh frozen plasma
- Use of anticoagulants that cannot be discontinued
- International normalized ratio >1.5 or platelet count <50.000
- Pregnancy or breast feeding
- Failure to sign the patient's or closest relative's informed consent