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NCT Number: NCT07585032

Safety and Efficacy of EUS-RFA in Pancreatic Insulinoma

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.

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Key information

Conditions

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

Age range

15 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sahlgrenska Univeristy Hospital

Gothenburg, Sweden

Location status: Recruiting

Location contact

Per Hedenström, Associate Professor

CONTACT

[email protected]

+46 31 3421000

Riadh Sadik, Associate Professor

CONTACT

+46 31 3421000

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EUS-RFA

Procedure

Treatment of insulinoma by EUS-RFA

Primary outcomes

  1. 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)

Secondary outcomes

  1. Patient safety

    Time frame: 30 days post-EUS-RFA

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

  2. 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. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Per Hedenström, Associate Professor

CONTACT

[email protected]

+46 31 3421000

Riadh Sadik, Associate Professor

CONTACT

+46 31 3421000

Sponsors and collaborators

Lead sponsor

Sahlgrenska University Hospital

Other

Registry information

Acronym: EUSRFAINSU

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
May 13, 2026
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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