Safety and Efficacy of EUS-RFA in Pancreatic Insulinoma (EUSRFAINSU)

May 8, 2026 updated by: Per Hedenström, Sahlgrenska University Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Riadh Sadik, Associate Professor
  • Phone Number: +46 31 3421000

Study Locations

  • Sweden
      • Gothenburg, Sweden
        • Recruiting
        • Sahlgrenska Univeristy Hospital
        • Contact:
        • Contact:
          • Riadh Sadik, Associate Professor
          • Phone Number: +46 31 3421000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Treatment of insulinoma by EUS-RFA
Control group
All patients subjected to surgery due to insulinoma during 2018-2024 acting as a historic control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
3-24 months post-EUS

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient safety
Time Frame: 30 days post-EUS-RFA
Adverse evnt rate according to Clavien-Dindo at 30 days post-EUS-RFA
30 days post-EUS-RFA
Imaging effect post-EUS-RFA with respect to tumor size
Time Frame: 3-24 months post-EUS-RFA
Imaging of the insulinoma by EUS post-EUS-RFA and thereby the assessment of tumor size
3-24 months post-EUS-RFA
Imaging effect post-EUS-RFA with respect to tumor vascularization
Time Frame: 3-24 months post EUS-RFA
Imaging of the insulinoma by EUS post-EUS-RFA and thereby the assessment of remaining tumor vascularization
3-24 months post EUS-RFA

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sahlgrenska University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 31, 2025

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

June 1, 2029

Study Registration Dates

First Submitted

April 27, 2026

First Submitted That Met QC Criteria

May 8, 2026

First Posted (Actual)

May 13, 2026

Study Record Updates

Last Update Posted (Actual)

May 13, 2026

Last Update Submitted That Met QC Criteria

May 8, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sahlgrenska EUS-RFA Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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