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

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

NCT ID: NCT05735912

Condition: Pancreatic Insulinoma

Conditions: Official terms:
Insulinoma

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Procedure
Intervention name: Endoscopic ultrasound-guided radio frequency ablation
Description: Radiofrequency ablation performed under endoscopic ultrasound guidance of pancreatic insulinoma
Arm group label: Endoscopic ultrasound-guided radiofrequency ablation

Intervention type: Procedure
Intervention name: Surgery
Description: Surgical resection of pancreatic insulinoma
Arm group label: Surgery

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.

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: University Hospital of Verona

Address:
City: Verona
Zip: 37138
Country: Italy

Status: Recruiting

Contact:
Last name: Stefano Francesco Crinò, MD

Investigator:
Last name: Stefano Francesco Crinò, MD
Email: Principal Investigator

Start date: March 1, 2023

Completion date: February 28, 2029

Lead sponsor:
Agency: Azienda Ospedaliera Universitaria Integrata Verona
Agency class: Other

Source: Azienda Ospedaliera Universitaria Integrata Verona

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05735912