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Recruiting NCT07585032

Safety and Efficacy of EUS-RFA in Pancreatic Insulinoma

— Observational Insulinoma; Pancreas

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: EUS-RFA.
Who it may be relevant to
Registry conditions: Insulinoma; Pancreas. Basic parameters: 15 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

  • Procedure EUS-RFA
    Treatment of insulinoma by EUS-RFA

Primary outcome measures

  • Clinical efficacy [Time frame: 3-24 months post-EUS]
Secondary outcome measures (3)
  • Patient safety [Time frame: 30 days post-EUS-RFA]
  • Imaging effect post-EUS-RFA with respect to tumor size [Time frame: 3-24 months post-EUS-RFA]
  • Imaging effect post-EUS-RFA with respect to tumor vascularization [Time frame: 3-24 months post EUS-RFA]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Sweden · 1 center
  • Sahlgrenska Univeristy Hospital — Gothenburg

Identifiers

NCT: NCT07585032 · Sahlgrenska EUS-RFA Study

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗