Pancreatic InsulinomaERASIN-RCTNCT05735912
EUS-RFA Versus Surgery for Pancreatic Insulinoma (ERASIN-RCT)
A study testing Endoscopic ultrasound-guided radio frequency ablation and Surgery in people with Pancreatic Insulinoma, run by Azienda Ospedaliera Universitaria Integrata Verona at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Insulinoma
- What is being tested?
- Endoscopic ultrasound-guided radio frequency ablation and Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2023to 31 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Endoscopic Ultrasound-guided RAdiofrequency Ablation Versus Surgical Resection for the Treatment of Pancreatic INsulinoma: a Multicenter Randomized Controlled Trial
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.
- Conditions
- Pancreatic Insulinoma
- Being tested
- Endoscopic ultrasound-guided radio frequency ablation, Surgery
- Medical subject headings
- Insulinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic ultrasound-guided radio frequency ablationProcedure or surgery
Radiofrequency ablation performed under endoscopic ultrasound guidance of pancreatic insulinoma
SurgeryProcedure or surgery
Surgical resection of pancreatic insulinoma
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic ultrasound-guided radiofrequency ablation | Experimental | 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. Receives: Procedure: Endoscopic ultrasound-guided radio frequency ablation |
| Surgery | Active comparator | 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. Receives: Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of adverse events
Rate of overall and severe adverse events will be recorded
Measured: Up to 72 months
Secondary outcomes (6)
Clinical effectiveness
Rate of patients experiencing symptoms disappearance
Measured: Up to 72 months
Evaluation of quality of life by questionnaire
Assessment of quality of life using a questionnaire
Measured: Up to 72 months
Length of hospital stay
Days of hospitalization
Measured: Up to 72 months
Recurrence
Rate of local or distant recurrence
Measured: Up to 72 months
Reintervention
Rate of reintervention
Measured: Up to 72 months
Pancreatic insufficiency
Rate of endocrine or exocrine pancreatic insufficiency
Measured: Up to 72 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start1 Mar 2023
- Primary completion31 Oct 2028 (estimated)
- Study completion31 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic InsulinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata Verona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefano Francesco Crinò, MD, Azienda Ospedaliera Universitaria Integrata Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05735912
- Sponsor's protocol ID
- 4121CESC
- Acronym
- ERASIN-RCT
- Status last verified
- Jan 2026
- First submitted
- 1 Feb 2023
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Ultrasound-guided RAdiofrequency Ablation Versus Surgical Resection for the Treatment of Pancreatic INsulinoma: a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05735912
- Acronym / sponsor ID
- ERASIN-RCT / 4121CESC
- Conditions
- Pancreatic Insulinoma
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata VeronaUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 21 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endoscopic ultrasound-guided radiofrequency ablation | Experimental | Procedure: Endoscopic ultrasound-guided radio frequency ablationEndoscopic 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. |
| Surgery | Active comparator | Procedure: SurgerySurgical 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic ultrasound-guided radio frequency ablationRadiofrequency ablation performed under endoscopic ultrasound guidance of pancreatic insulinoma | Procedure or surgery | Endoscopic ultrasound-guided radiofrequency ablation |
| SurgerySurgical resection of pancreatic insulinoma | Procedure or surgery | Surgery |
Primary outcome
Rate of adverse events
Time frame: Up to 72 months
Rate of overall and severe adverse events will be recorded
6 secondary outcomes
Clinical effectiveness
Time frame: Up to 72 months
Evaluation of quality of life by questionnaire
Time frame: Up to 72 months
Length of hospital stay
Time frame: Up to 72 months
Recurrence
Time frame: Up to 72 months
Reintervention
Time frame: Up to 72 months
Pancreatic insufficiency
Time frame: Up to 72 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic ultrasound-guided radio frequency ablation and Surgery in people with Pancreatic Insulinoma, run by Azienda Ospedaliera Universitaria Integrata Verona at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of adverse events (time frame: Up to 72 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.