Safety and Efficacy of EUS-RFA in Pancreatic Insulinoma

NCT07585032 | Recruiting DMC

• 1 other identifier: Sahlgrenska EUS-RFA Study
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Insulinoma; Pancreas

Keywords

endosonography; insulinoma; radiofrequency ablation

Outcome Measures

Primary Outcomes (1)

• Clinical efficacy

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

  3-24 months post-EUS

Secondary Outcomes (3)

• Patient safety

  30 days post-EUS-RFA

• Imaging effect post-EUS-RFA with respect to tumor size

  3-24 months post-EUS-RFA

• Imaging effect post-EUS-RFA with respect to tumor vascularization

  3-24 months post EUS-RFA

Study Arms (2)

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

EUS-RFA PROCEDURE

Treatment of insulinoma by EUS-RFA

Prospective cohort subjected to EUS-RFA

Eligibility Criteria

• Age: 15 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead

Study Sites (1)

Sahlgrenska Univeristy Hospital

Gothenburg, Sweden

RECRUITING

MeSH Terms

Conditions

Insulinoma

Condition Hierarchy (Ancestors)

Adenoma, Islet Cell; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Pancreatic Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Central Study Contacts

Per Hedenström, Associate Professor

CONTACT

+46 31 3421000; per.hedenstrom@vgregion.se

Riadh Sadik, Associate Professor

CONTACT

+46 31 3421000

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant

Study Record Dates

• First Submitted: April 27, 2026
• First Posted: May 13, 2026
• Study Start: March 31, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: May 13, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)