Comparing EUS-RFA and surgery for treating pancreatic insulinoma
Endoscopic Ultrasound-guided RAdiofrequency Ablation Versus Surgical Resection for the Treatment of Pancreatic INsulinoma: a Multicenter Randomized Controlled Trial
This study is testing whether a new treatment called EUS-RFA is as safe and effective as surgery for people with pancreatic insulinoma.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Azienda Ospedaliera Universitaria Integrata Verona Academic / other |
| Locations | 1 site (Verona) |
| Trial ID | NCT05735912 on ClinicalTrials.gov |
What this trial studies
This multicenter randomized controlled trial aims to evaluate the safety and efficacy of endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) compared to surgical resection for patients with pancreatic insulinoma. Participants will be randomly assigned to receive either EUS-RFA or surgery, and the study will assess the rate of adverse events and clinical outcomes associated with each treatment. The goal is to determine if EUS-RFA is a safer and equally effective alternative to surgery for this condition.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older diagnosed with a single pancreatic insulinoma nodule that is 2cm or smaller.
Not a fit: Patients with multiple pancreatic nodules, metastatic tumors, or those unfit for surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a less invasive treatment option for patients with pancreatic insulinoma.
How similar studies have performed: While there is limited data on EUS-RFA for pancreatic insulinoma, similar approaches in other conditions have shown promising results, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Verona
- University Hospital of Verona — Verona, Italy (Recruiting)
Study contacts
- Study coordinator: Stefano Francesco Crinò, MD
- Email: stefanofrancesco.crino@aovr.veneto.it
- Phone: 00390458126191
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.