EUS-RFA Versus Surgery for Pancreatic Insulinoma (ERASIN-RCT) (NCT05735912) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
EUS-RFA Versus Surgery for Pancreatic Insulinoma (ERASIN-RCT)
Italy60 participantsStarted 2023-03-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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