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

Endoscopic Ultrasound-guided RAdiofrequency Ablation Versus Surgical Resection for the Treatment of Pancreatic INsulinoma: a Multicenter Randomized Controlled Trial

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 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