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

Not Applicable

Recruiting

• Conditions: Pancreatic Insulinoma

• Registration Number: NCT05735912
• Lead Sponsor: Azienda Ospedaliera Universitaria Integrata Verona

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-01
• Study First Submitted QC: 2023-02-09
• Study First Posted: 2023-02-21
• Study Start: 2023-03-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-06
• Last Update Posted: 2024-12-11
• Primary Completion: 2026-02-28
• Study Completion: 2029-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Rate of adverse events	Up to 72 months	Rate of overall and severe adverse events will be recorded

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital of Verona; 🇮🇹 Verona, Italy