EUS-RFA Versus Surgery for Pancreatic Insulinoma (ERASIN-RCT)
NCT ID: NCT05735912
Last Updated: 2024-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2023-03-01
2029-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Endoscopic ultrasound-guided radiofrequency ablation
Endoscopic ultrasound-guided radiofrequency ablation will be performed using the "EUSRA" system (Taewoong, Seoul, Korea). The system consists of a 19-gauge needle electrode (140-cm long), a radiofrequency current generator (VIVA RF generator; Taewoong), and an inner cooling system that circulates chilled saline solution during the radiofrequency ablation procedure. The inner metal part is insulated over its entire length, with the exception of the terminal 5 to 20mm for energy delivery. The needle electrode is attached to the radiofrequency current generator and to a cooling pump. The generator, in addition to providing radiofrequency current, allows the control of physical power and impedance parameters.
Endoscopic ultrasound-guided radio frequency ablation
Radiofrequency ablation performed under endoscopic ultrasound guidance of pancreatic insulinoma
Surgery
Surgical resection will be performed in an inpatient setting. The type and extension of surgical resection, as well as need for lymphadenectomy, will be decided by the treating surgeons according to the tumor position, distance from the main pancreatic duct, and local expertise.
Surgery
Surgical resection of pancreatic insulinoma
Interventions
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Endoscopic ultrasound-guided radio frequency ablation
Radiofrequency ablation performed under endoscopic ultrasound guidance of pancreatic insulinoma
Surgery
Surgical resection of pancreatic insulinoma
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Azienda Ospedaliera Universitaria Integrata Verona
OTHER
Responsible Party
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Stefano Francesco Crinò, MD
Doctor
Locations
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University Hospital of Verona
Verona, , Italy
Countries
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Central Contacts
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Facility Contacts
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Stefano Francesco Crinò, MD
Role: primary
Other Identifiers
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4121CESC
Identifier Type: -
Identifier Source: org_study_id