NCT05735912Active, not recruiting
EUS-RFA Versus Surgery for Pancreatic Insulinoma (ERASIN-RCT)
Endoscopic Ultrasound-guided RAdiofrequency Ablation Versus Surgical Resection for the Treatment of Pancreatic INsulinoma: a Multicenter Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 13 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 1 Feb 2023
- Start date
- 1 Mar 2023
- Primary completion date
- 31 Oct 2028
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata Verona
- NCT number
- NCT05735912
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 1 Mar 2023 to the primary completion date, 31 Oct 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Unfit for surgery or high-risk surgical patients
- Endoscopic ultrasound not feasible for surgical altered anatomy
Other illness
- Known bleeding disorder that cannot be sufficiently corrected with co-fact or fresh frozen plasma
- Failure to sign the patient's or closest relative's informed consent
Lab values
- International normalized ratio \>1.5 or platelet count \<50.000
Other
- 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
- Use of anticoagulants that cannot be discontinued
- Pregnancy or breast feeding
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital of Verona Coordinator of this site? Confirm its status | Verona | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.