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

Pancreatic Insulinoma Clinical Trial

— ERASIN-RCT  

Official title:

Endoscopic Ultrasound-guided RAdiofrequency Ablation Versus Surgical Resection for the Treatment of Pancreatic INsulinoma: a Multicenter Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05735912
• Other study ID #: 4121CESC
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: February 28, 2029

Study information

• Verified date: March 2023
• Source: Azienda Ospedaliera Universitaria Integrata Verona
• Contact: Stefano Francesco Crinò, MD
• Phone: 00390458126191
• Email: stefanofrancesco.crino[@]aovr.veneto.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: February 28, 2029
• Est. primary completion date: February 28, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Insulinoma
• Pancreatic Insulinoma

Intervention

Procedure:
• Endoscopic ultrasound-guided radio frequency ablation
Radiofrequency ablation performed under endoscopic ultrasound guidance of pancreatic insulinoma
• Surgery
Surgical resection of pancreatic insulinoma

Locations

Country	Name	City	State
Italy	University Hospital of Verona	Verona

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Universitaria Integrata Verona

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of adverse events	Rate of overall and severe adverse events will be recorded	Up to 72 months
Secondary	Clinical effectiveness	Rate of patients experiencing symptoms disappearance	Up to 72 months
Secondary	Evaluation of quality of life by questionnaire	Assessment of quality of life using a questionnaire	Up to 72 months
Secondary	Length of hospital stay	Days of hospitalization	Up to 72 months
Secondary	Recurrence	Rate of local or distant recurrence	Up to 72 months
Secondary	Reintervention	Rate of reintervention	Up to 72 months
Secondary	Pancreatic insufficiency	Rate of endocrine or exocrine pancreatic insufficiency	Up to 72 months