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RecruitingNCT07585032EUSRFAINSUUpdated May 13, 2026

Safety and Efficacy of EUS-RFA in Pancreatic Insulinoma

An observational study in Insulinoma; Pancreas, sponsored by Sahlgrenska University Hospital. Recruiting at 1 site in Sweden. Open to participants aged 15 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-05-13.

Sponsored by Sahlgrenska University Hospital · Observational

From the registry’s dates

  • Started Mar 2025; still recruiting 1 year 7 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20
Ages
15 Years to 80 Years
Sex
All
01

Study 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 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).
02

Conditions studied

  • Insulinoma; Pancreas

Browse trials for

Keywords

  • endosonography
  • insulinoma
  • radiofrequency ablation
03

In context

Insulinoma

62 studies on the registry are indexed under Insulinoma; 12 are open to participants now.

Browse Insulinoma studies →

Lead sponsor

Sahlgrenska University Hospital is the lead sponsor of 263 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

All patients referred to Sahlgrenska UH for the diagnosis and treatment of pancreatic insulinoma.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Insulinoma verified by pathology (often from EUS-FNB-sampling)

Exclusion criteria

Exclusion Criteria:

  • Patients unwilling to participate
  • Patients unable to understand and obtain written informed conscent
  • Severe comorbidity
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20 participants (estimated)
Patient registry
No

Groups and cohorts

  • Prospective cohort subjected to EUS-RFA

    All patientens enrolled prospectively from 2025 and onwards subjected to EUS-RFA as treatemtn for pancreatic insulinoma

    Procedure: EUS-RFA

  • Control group

    All patients subjected to surgery due to insulinoma during 2018-2024 acting as a historic control group

Interventions

  • ProcedureEUS-RFA

    Treatment of insulinoma by EUS-RFA

06

What researchers measure

Primary outcomes

  1. Clinical efficacy

    Symptom-free survival after EUS-RFA (no clinical signs of residual disease, i.e. insulin-producing insulinoma cells)

    Time frame: 3-24 months post-EUS

Secondary outcomes

  1. Patient safety

    Adverse evnt rate according to Clavien-Dindo at 30 days post-EUS-RFA

    Time frame: 30 days post-EUS-RFA

  2. 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

    Time frame: 3-24 months post-EUS-RFA

  3. 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

    Time frame: 3-24 months post EUS-RFA

07

Study locations

1 of 1 sites recruiting
  • Sahlgrenska Univeristy Hospital
    Gothenburg, Sweden
    Recruiting
    • Per Hedenström, Associate Professor · Contactper.hedenstrom@vgregion.se · +46 31 3421000
    • Riadh Sadik, Associate Professor · Contact+46 31 3421000
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Mar 2025 (actual). Primary completion is estimated for Dec 2028, 45 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 27, 2026
First posted
May 13, 2026
StartActual
Mar 31, 2025
Primary completionEst.
Dec 2028
CompletionEst.
Jun 2029
Last update
May 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07585032
Responsible party
Per Hedenström (Senior Consultant, Sahlgrenska University Hospital) — Principal investigator
First posted
May 13, 2026
Start date
Mar 31, 2025
Primary completion
Dec 2028 (estimated)
Completion
Jun 2029 (estimated)
Last update
May 13, 2026

Study contacts

Per Hedenström, Associate Professor
Contact
per.hedenstrom@vgregion.se
+46 31 3421000
Riadh Sadik, Associate Professor
Contact
+46 31 3421000

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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