EUS-RFA Versus Surgery for Pancreatic Insulinoma (ERASIN-RCT)

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.

Inclusion Criteria:Age ≥18 yearsDiagnosis 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 ultrasoundTumor ≤ 2cmInformed 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 ductMetastatic tumor at the time of diagnosisMultiple pancreatic nodulesDiagnosis of multiple endocrine neoplasia type 1 according to guidelinesUnfit for surgery or high-risk surgical patientsEndoscopic ultrasound not feasible for surgical altered anatomyKnown bleeding disorder that cannot be sufficiently corrected with co-fact or fresh frozen plasmaUse of anticoagulants that cannot be discontinuedInternational normalized ratio >1.5 or platelet count <50.000Pregnancy or breast feedingFailure to sign the patient's or closest relative's informed consent