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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Radiofrequency ablation performed under endoscopic ultrasound guidance of pancreatic insulinoma
Surgical resection of pancreatic insulinoma
University Hospital of Verona
Verona, Italy
Rate of adverse events
Rate of overall and severe adverse events will be recorded
Time frame: Up to 72 months
Clinical effectiveness
Rate of patients experiencing symptoms disappearance
Time frame: Up to 72 months
Evaluation of quality of life by questionnaire
Assessment of quality of life using a questionnaire
Time frame: Up to 72 months
Length of hospital stay
Days of hospitalization
Time frame: Up to 72 months
Recurrence
Rate of local or distant recurrence
Time frame: Up to 72 months
Reintervention
Rate of reintervention
Time frame: Up to 72 months
Pancreatic insufficiency
Rate of endocrine or exocrine pancreatic insufficiency
Time frame: Up to 72 months
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