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Clinical Trials in Italy / NCT05735912
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EUS-RFA Versus Surgery for Pancreatic Insulinoma (ERASIN-RCT)

NCT05735912 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2023-03-01
Last updated
2026-01-13

Condition(s) studied

Pancreatic Insulinoma

Investigational drug(s) / intervention(s)

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)

Trial sites (1)

FacilityCityRegionStatus
University Hospital of Verona Verona Italy

More Azienda Ospedaliera Universitaria Integrata Verona trials in Italy

Official registry record

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.

View NCT05735912 on ClinicalTrials.gov ↗ ← All trials in Italy