Insulinoma; PancreasEUSRFAINSUNCT07585032
Safety and Efficacy of EUS-RFA in Pancreatic Insulinoma
An observational study of Insulinoma; Pancreas, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial summary
Transcutaneous and EUS-guided radiofrequency ablation are both modern modalities to apply in the managemnet of various malignancies. In the current study the investigators aim to study the technical feasibility, patient safety and clinical efficacy of EUS-RFA for the treatment of pancreatic insulinoma. Read more about this study
- Who is it for?
- Ages 15 to 80 years
- Conditions the study is for
- Insulinoma; Pancreas
- What is being tested?
- EUS-RFA
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteSweden
- Study dates
- 31 Mar 2025to Jun 2029
- Phase
- Observational
- 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 15 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients referred to Sahlgrenska UH for the diagnosis and treatment of pancreatic insulinoma.
Who may be able to join
- Insulinoma verified by pathology (often from EUS-FNB-sampling)
Who cannot join
- Patients unwilling to participate
- Patients unable to understand and obtain written informed conscent
- Severe comorbidity
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Riadh Sadik, Associate Professor contact
Sweden1 site, 1 recruiting
- Recruiting
Sahlgrenska Univeristy Hospital
Gothenburg
Per Hedenström, Associate Professor, +46 31 3421000, per.hedenstrom@vgregion.se
Riadh Sadik, Associate Professor, +46 31 3421000
About this study
Transcutaneous and EUS-guided radiofrequency ablation are both modern modalities to apply in the managemnet of various malignancies.
In the current study the investigators aim to study the technical feasibility, patient safety and clinical efficacy of EUS-RFA for the treatment of pancreatic insulinoma.
Read the detailed description
Patients (P): Alla patients referred to Sahlgrenska University Hospital for the diagnostic work-up and management of a suspected pancreatic insulinoma.
Intervention (I): EUS-RFA
Control group (C): Patients with insulinoma treated with conventional surgery during the time frame 2018-2025 (historic controls).
Outcome (O):
- Technical feasibility
- Patient safety
- Clinical efficacy (follow-up with biochemistry and imaging at 3, 6, 12, and 24 months post-EUS-RFA).
- Conditions
- Insulinoma; Pancreas
- Being tested
- EUS-RFA
- Keywords
- endosonography, insulinoma, radiofrequency ablation
- Medical subject headings
- Insulinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUS-RFAProcedure or surgery
Treatment of insulinoma by EUS-RFA
| Study group | Role | What they receive |
|---|---|---|
| Prospective cohort subjected to EUS-RFA | All patientens enrolled prospectively from 2025 and onwards subjected to EUS-RFA as treatemtn for pancreatic insulinoma Receives: Procedure: EUS-RFA | |
| Control group | All patients subjected to surgery due to insulinoma during 2018-2024 acting as a historic control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical efficacy
Symptom-free survival after EUS-RFA (no clinical signs of residual disease, i.e. insulin-producing insulinoma cells)
Measured: 3-24 months post-EUS
Secondary outcomes (3)
Patient safety
Adverse evnt rate according to Clavien-Dindo at 30 days post-EUS-RFA
Measured: 30 days post-EUS-RFA
Imaging effect post-EUS-RFA with respect to tumor size
Imaging of the insulinoma by EUS post-EUS-RFA and thereby the assessment of tumor size
Measured: 3-24 months post-EUS-RFA
Imaging effect post-EUS-RFA with respect to tumor vascularization
Imaging of the insulinoma by EUS post-EUS-RFA and thereby the assessment of remaining tumor vascularization
Measured: 3-24 months post EUS-RFA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start31 Mar 2025
- Primary completionDec 2028 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulinoma; PancreasStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Per Hedenström, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07585032
- Sponsor's protocol ID
- Sahlgrenska EUS-RFA Study
- Acronym
- EUSRFAINSU
- Status last verified
- May 2026
- First submitted
- 27 Apr 2026
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of EUS-RFA in Pancreatic Insulinoma
- ClinicalTrials.gov ID
- NCT07585032
- Acronym / sponsor ID
- EUSRFAINSU / Sahlgrenska EUS-RFA Study
- Conditions
- Insulinoma; Pancreas
- Keywords
- endosonography, insulinoma, radiofrequency ablation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- 31 Mar 2025 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 13 May 2026 (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.
Transcutaneous and EUS-guided radiofrequency ablation are both modern modalities to apply in the managemnet of various malignancies.
In the current study the investigators aim to study the technical feasibility, patient safety and clinical efficacy of EUS-RFA for the treatment of pancreatic insulinoma.
Detailed description
Patients (P): Alla patients referred to Sahlgrenska University Hospital for the diagnostic work-up and management of a suspected pancreatic insulinoma.
Intervention (I): EUS-RFA
Control group (C): Patients with insulinoma treated with conventional surgery during the time frame 2018-2025 (historic controls).
Outcome (O):
- Technical feasibility
- Patient safety
- Clinical efficacy (follow-up with biochemistry and imaging at 3, 6, 12, and 24 months post-EUS-RFA).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prospective cohort subjected to EUS-RFA | – | Procedure: EUS-RFAAll patientens enrolled prospectively from 2025 and onwards subjected to EUS-RFA as treatemtn for pancreatic insulinoma |
| Control group | – | –All patients subjected to surgery due to insulinoma during 2018-2024 acting as a historic control group |
Who may qualify
- Ages
- 15 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients referred to Sahlgrenska UH for the diagnosis and treatment of pancreatic insulinoma.
Key inclusion criteria (1 listed)
- Insulinoma verified by pathology (often from EUS-FNB-sampling)
Key exclusion criteria (3 listed)
- Patients unwilling to participate
- Patients unable to understand and obtain written informed conscent
- Severe comorbidity
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 |
|---|---|---|
| EUS-RFATreatment of insulinoma by EUS-RFA | Procedure or surgery | Prospective cohort subjected to EUS-RFA |
Primary outcome
Clinical efficacy
Time frame: 3-24 months post-EUS
Symptom-free survival after EUS-RFA (no clinical signs of residual disease, i.e. insulin-producing insulinoma cells)
3 secondary outcomes
Patient safety
Time frame: 30 days post-EUS-RFA
Imaging effect post-EUS-RFA with respect to tumor size
Time frame: 3-24 months post-EUS-RFA
Imaging effect post-EUS-RFA with respect to tumor vascularization
Time frame: 3-24 months post EUS-RFA
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 May 2026.
- Individual participant dataSharing planned: No
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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.
Riadh Sadik, Associate Professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Insulinoma; Pancreas, run by Sahlgrenska University Hospital at 1 site in Sweden.
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 1 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 13 May 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 Sweden. 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?
Contact Per Hedenström, Associate Professor (+46 31 3421000, per.hedenstrom@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical efficacy (time frame: 3-24 months post-EUS). 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 May 2026.