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

Primary Purpose

Pancreatic Insulinoma

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Endoscopic ultrasound-guided radio frequency ablation
Surgery
Sponsored by
Azienda Ospedaliera Universitaria Integrata Verona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Insulinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital of VeronaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Endoscopic ultrasound-guided radiofrequency ablation

Surgery

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Rate of adverse events
Rate of overall and severe adverse events will be recorded

Secondary Outcome Measures

Clinical effectiveness
Rate of patients experiencing symptoms disappearance
Evaluation of quality of life by questionnaire
Assessment of quality of life using a questionnaire
Length of hospital stay
Days of hospitalization
Recurrence
Rate of local or distant recurrence
Reintervention
Rate of reintervention
Pancreatic insufficiency
Rate of endocrine or exocrine pancreatic insufficiency

Full Information

First Posted
February 1, 2023
Last Updated
March 17, 2023
Sponsor
Azienda Ospedaliera Universitaria Integrata Verona
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1. Study Identification

Unique Protocol Identification Number
NCT05735912
Brief Title
EUS-RFA Versus Surgery for Pancreatic Insulinoma (ERASIN-RCT)
Acronym
ERASIN-RCT
Official Title
Endoscopic Ultrasound-guided RAdiofrequency Ablation Versus Surgical Resection for the Treatment of Pancreatic INsulinoma: a Multicenter Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
February 28, 2026 (Anticipated)
Study Completion Date
February 28, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Ospedaliera Universitaria Integrata Verona

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Insulinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Endoscopic ultrasound-guided radiofrequency ablation
Arm Type
Experimental
Arm Description
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.
Arm Title
Surgery
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Endoscopic ultrasound-guided radio frequency ablation
Intervention Description
Radiofrequency ablation performed under endoscopic ultrasound guidance of pancreatic insulinoma
Intervention Type
Procedure
Intervention Name(s)
Surgery
Intervention Description
Surgical resection of pancreatic insulinoma
Primary Outcome Measure Information:
Title
Rate of adverse events
Description
Rate of overall and severe adverse events will be recorded
Time Frame
Up to 72 months
Secondary Outcome Measure Information:
Title
Clinical effectiveness
Description
Rate of patients experiencing symptoms disappearance
Time Frame
Up to 72 months
Title
Evaluation of quality of life by questionnaire
Description
Assessment of quality of life using a questionnaire
Time Frame
Up to 72 months
Title
Length of hospital stay
Description
Days of hospitalization
Time Frame
Up to 72 months
Title
Recurrence
Description
Rate of local or distant recurrence
Time Frame
Up to 72 months
Title
Reintervention
Description
Rate of reintervention
Time Frame
Up to 72 months
Title
Pancreatic insufficiency
Description
Rate of endocrine or exocrine pancreatic insufficiency
Time Frame
Up to 72 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stefano Francesco Crinò, MD
Phone
00390458126191
Email
stefanofrancesco.crino@aovr.veneto.it
Facility Information:
Facility Name
University Hospital of Verona
City
Verona
ZIP/Postal Code
37138
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefano Francesco Crinò, MD
First Name & Middle Initial & Last Name & Degree
Stefano Francesco Crinò, MD

12. IPD Sharing Statement

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

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