ERASIN-RCT
Endoscopic Ultrasound-guided RAdiofrequency Ablation Versus Surgical Resection for the Treatment of Pancreatic INsulinoma: a Multicenter Randomized Controlled Trial
Sponsor study identifier
interventional
60
1 country
1
Study Start
March 1, 2023
Actual (reported)Primary Completion
October 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
October 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 1, 2023
Actual (reported)February 21, 2023
Actual (reported)March 1, 2023
Actual (reported)October 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
October 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Rate of adverse events
Rate of overall and severe adverse events will be recorded
Up to 72 months
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
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.
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.
Radiofrequency ablation performed under endoscopic ultrasound guidance of pancreatic insulinoma
Surgical resection of pancreatic insulinoma
University Hospital of Verona
Verona, 37138, Italy
First Submitted
February 1, 2023
First Posted
February 21, 2023
Study Start
March 1, 2023
Actual (reported)Primary Completion
October 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Study Completion
October 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
January 13, 2026
Record last verified: 2026-01
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Source: ClinicalTrials.gov.
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