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

  • End date
    Feb 28, 2029
  • participants needed
  • sponsor
    Azienda Ospedaliera Universitaria Integrata Verona
Updated on 9 April 2023


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.

Condition Pancreatic Insulinoma
Treatment Surgery, Endoscopic ultrasound-guided radio frequency ablation
Clinical Study IdentifierNCT05735912
SponsorAzienda Ospedaliera Universitaria Integrata Verona
Last Modified on9 April 2023


Yes No Not Sure

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
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