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

Study Overview
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Brief Summary
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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.

Official Title
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Endoscopic Ultrasound-guided RAdiofrequency Ablation Versus Surgical Resection for the Treatment of Pancreatic INsulinoma: a Multicenter Randomized Controlled Trial

Conditions
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Pancreatic Insulinoma

Intervention / Treatment
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* Procedure: Endoscopic ultrasound-guided radio frequency ablation
* Procedure: Surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endoscopic ultrasound-guided radiofrequency ablation<br>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<br>* Radiofrequency ablation performed under endoscopic ultrasound guidance of pancreatic insulinoma<br>|
| Active Comparator: Surgery<br>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<br>* Surgical resection of pancreatic insulinoma<br>|

What is the study measuring?
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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 |