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

Study Overview

• Status: Active, not recruiting
• Conditions: Pancreatic Insulinoma
• Intervention / Treatment: Procedure: Endoscopic ultrasound-guided radio frequency ablation; Procedure: Surgery

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Verona, Italy, 37138
    • University Hospital of Verona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Endoscopic ultrasound-guided radiofrequency ablation; Endoscopic ultrasound-guided radiofrequency ablation will be performed using the "EUSRA" system (Taewoong, Seoul, Korea). The system consists of a 19-gauge needle electrode (140-cm long), a radiofrequency current generator (VIVA RF generator; Taewoong), and an inner cooling system that circulates chilled saline solution during the radiofrequency ablation procedure. The inner metal part is insulated over its entire length, with the exception of the terminal 5 to 20mm for energy delivery. The needle electrode is attached to the radiofrequency current generator and to a cooling pump. The generator, in addition to providing radiofrequency current, allows the control of physical power and impedance parameters.	Procedure: Endoscopic ultrasound-guided radio frequency ablation; Radiofrequency ablation performed under endoscopic ultrasound guidance of pancreatic insulinoma
Active Comparator: Surgery; Surgical resection will be performed in an inpatient setting. The type and extension of surgical resection, as well as need for lymphadenectomy, will be decided by the treating surgeons according to the tumor position, distance from the main pancreatic duct, and local expertise.	Procedure: Surgery; Surgical resection of pancreatic insulinoma

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of adverse events	Rate of overall and severe adverse events will be recorded	Up to 72 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical effectiveness	Rate of patients experiencing symptoms disappearance	Up to 72 months
Evaluation of quality of life by questionnaire	Assessment of quality of life using a questionnaire	Up to 72 months
Length of hospital stay	Days of hospitalization	Up to 72 months
Recurrence	Rate of local or distant recurrence	Up to 72 months
Reintervention	Rate of reintervention	Up to 72 months
Pancreatic insufficiency	Rate of endocrine or exocrine pancreatic insufficiency	Up to 72 months

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera Universitaria Integrata Verona

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Estimated): October 31, 2028
• Study Completion (Estimated): October 31, 2028

Study Registration Dates

• First Submitted: February 1, 2023
• First Submitted That Met QC Criteria: February 9, 2023
• First Posted (Actual): February 21, 2023

Study Record Updates

• Last Update Posted (Actual): January 13, 2026
• Last Update Submitted That Met QC Criteria: January 11, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Digestive System Neoplasms; Digestive System Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Neoplasms, Glandular and Epithelial; Adenoma; Pancreatic Neoplasms; Adenoma, Islet Cell; Insulinoma; Surgical Procedures, Operative
• Other Study ID Numbers: 4121CESC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No