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

Last updated: December 6, 2024
Sponsor: Azienda Ospedaliera Universitaria Integrata Verona
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pancreatic Cancer

Primary Insulin Hypersecretion

Treatment

Endoscopic ultrasound-guided radio frequency ablation

Surgery

Clinical Study ID

NCT05735912
4121CESC
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

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/ormagnetic resonance imaging, and/or endoscopic ultrasound

  • Tumor ≤ 2cm

  • Informed consent provided by the patient or closest relative.

Exclusion

Exclusion Criteria:

  • G2 with Ki-67 >5% on histological examination at EUS-guided biopsy samples (ifperformed)

  • Distance between lesion and main pancreatic duct ≤ 1mm or upstream dilation of themain 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 freshfrozen 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

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Endoscopic ultrasound-guided radio frequency ablation
Phase:
Study Start date:
March 01, 2023
Estimated Completion Date:
February 28, 2029

Connect with a study center

  • University Hospital of Verona

    Verona, 37138
    Italy

    Active - Recruiting

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