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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
University Hospital of Verona
RECRUITING
Verona
Contact Information
Primary
Stefano Francesco Crinò, MD
stefanofrancesco.crino@aovr.veneto.it
00390458126191
Time Frame
Start Date: 2023-03-01
Estimated Completion Date: 2029-02-28
Participants
Target number of participants: 60
Treatments
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), 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.
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 duct, and local expertise.
Related Therapeutic Areas
Sponsors
Leads: Azienda Ospedaliera Universitaria Integrata Verona

This content was sourced from clinicaltrials.gov