Endoscopic ultrasound-guided radio frequency ablationSurgery
Endoscopic ultrasound-guided radio frequency ablation: Radiofrequency ablation performed under endoscopic ultrasound guidance of pancreatic insulinoma
Surgery: Surgical resection of pancreatic insulinoma
Study summary
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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Rate of adverse events — Up to 72 months Rate of overall and severe adverse events will be recorded
Trial sites (1)
Facility
City
Region
Status
University Hospital of Verona
Verona
Italy
More Azienda Ospedaliera Universitaria Integrata Verona trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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