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

NCT05735912 | Active Not Recruiting

• 1 other identifier: 4121CESC
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pancreatic Insulinoma

Outcome Measures

Primary Outcomes (1)

• Rate of adverse events

  Rate of overall and severe adverse events will be recorded

  Up to 72 months

Secondary Outcomes (6)

• Clinical effectiveness

  Up to 72 months

• Evaluation of quality of life by questionnaire

  Up to 72 months

• Length of hospital stay

  Up to 72 months

• Recurrence

  Up to 72 months

• Reintervention

  Up to 72 months

Study Arms (2)

Endoscopic ultrasound-guided radiofrequency ablation

EXPERIMENTAL

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

Surgery

ACTIVE COMPARATOR

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

Interventions

Endoscopic ultrasound-guided radio frequency ablation PROCEDURE

Radiofrequency ablation performed under endoscopic ultrasound guidance of pancreatic insulinoma

Endoscopic ultrasound-guided radiofrequency ablation

Surgery PROCEDURE

Surgical resection of pancreatic insulinoma

Surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Ospedaliera Universitaria Integrata Verona: lead

Study Sites (1)

University Hospital of Verona

Verona, 37138, Italy

Location

MeSH Terms

Conditions

Insulinoma

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Adenoma, Islet Cell; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Pancreatic Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: February 1, 2023
• First Posted: February 21, 2023
• Study Start: March 1, 2023
• Primary Completion (Estimated): October 31, 2028
• Study Completion (Estimated): October 31, 2028
• Last Updated: January 13, 2026

Record last verified: 2026-01

Locations

IT (1)