Pancreatic Insulinoma
Conditions
Brief 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.
Interventions
PROCEDUREEndoscopic ultrasound-guided radio frequency ablation
Radiofrequency ablation performed under endoscopic ultrasound guidance of pancreatic insulinoma
PROCEDURESurgery
Surgical resection of pancreatic insulinoma
Sponsors
Azienda Ospedaliera Universitaria Integrata Verona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of adverse events | Up to 72 months | Rate of overall and severe adverse events will be recorded |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of quality of life by questionnaire | Up to 72 months | Assessment of quality of life using a questionnaire |
| Length of hospital stay | Up to 72 months | Days of hospitalization |
| Clinical effectiveness | Up to 72 months | Rate of patients experiencing symptoms disappearance |
| Reintervention | Up to 72 months | Rate of reintervention |
| Pancreatic insufficiency | Up to 72 months | Rate of endocrine or exocrine pancreatic insufficiency |
| Recurrence | Up to 72 months | Rate of local or distant recurrence |
Countries
Italy
Outcome results
None listed