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

Launched by AZIENDA OSPEDALIERA UNIVERSITARIA INTEGRATA VERONA · Feb 9, 2023

Keywords

ClinConnect Summary

The ERASIN-RCT trial is studying two different treatments for pancreatic insulinoma, which is a type of tumor in the pancreas that produces insulin. The researchers want to find out which treatment is safer and whether they are equally effective. Participants in the trial will be randomly assigned to receive either endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA), a less invasive procedure that uses heat to destroy the tumor, or traditional surgery to remove the tumor.

To join the trial, patients should be at least 18 years old, have been diagnosed with pancreatic insulinoma, and have a single tumor that is no larger than 2 centimeters. They should also not have any signs of the cancer spreading and should be able to provide informed consent. Throughout the trial, participants will be monitored for any side effects and the success of the treatments. This study is currently recruiting patients and aims to help determine the best approach to treating this condition.

Gender

ALL

Eligibility criteria

• 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