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

Study Overview

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

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.

N/A

Pancreatic Insulinoma

PROCEDURE: Endoscopic ultrasound-guided radio frequency ablation
PROCEDURE: Surgery

4121CESC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2023-02-01	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-12-06
First Submitted that Met QC Criteria 2023-02-09	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-12-11
First Posted (ACTUAL) 2023-02-21	Results First Posted N/A	Last Verified 2024-12

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

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), a	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 du	PROCEDURE: Surgery Surgical resection of pancreatic insulinoma

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), a

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 du

PROCEDURE: Surgery

Surgical resection of pancreatic insulinoma

Primary Outcome Measures	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	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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Stefano Francesco Crinò, MD

Phone Number: 00390458126191

Email: stefanofrancesco.crino@aovr.veneto.it

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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Clinical Trial Record