Safety and Efficacy of EUS-RFA in Pancreatic Insulinoma

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07585032

Acronym

EUSRFAINSU

Enrollment

Registered

2026-05-13

Start date

2025-03-31

Completion date

2029-06-01

Last updated

2026-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insulinoma; Pancreas

Keywords

endosonography, insulinoma, radiofrequency ablation

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.

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).

Interventions

PROCEDUREEUS-RFA

Treatment of insulinoma by EUS-RFA

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

15 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Clinical efficacy	3-24 months post-EUS	Symptom-free survival after EUS-RFA (no clinical signs of residual disease, i.e. insulin-producing insulinoma cells)

Secondary

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

Countries

Sweden

Contacts

CONTACTPer Hedenström, Associate Professor

per.hedenstrom@vgregion.se+46 31 3421000

CONTACTRiadh Sadik, Associate Professor

+46 31 3421000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 14, 2026