EUS-guided radiofrequency ablation for pancreatic insulinoma safety and effectiveness
Safety and Efficacy of EUS-RFA in Pancreatic Insulinoma
This project will try EUS-guided radiofrequency ablation (EUS-RFA) to treat people with pathology-confirmed pancreatic insulinoma and compare safety and outcomes to historic surgical patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 15 Years to 80 Years |
| Sex | All |
| Sponsor | Sahlgrenska University Hospital Academic / other |
| Locations | 1 site (Gothenburg) |
| Trial ID | NCT07585032 on ClinicalTrials.gov |
What this trial studies
EUS-guided radiofrequency ablation (EUS-RFA) is offered to patients referred to Sahlgrenska University Hospital with suspected and pathology-confirmed pancreatic insulinoma. This observational, single-center project will record technical feasibility, patient safety, and clinical efficacy of EUS-RFA and compare outcomes to historic surgical controls treated from 2018–2025. Clinical follow-up includes biochemical testing and imaging at 3, 6, 12, and 24 months to monitor glucose control, tumor response, and complications. Eligible patients typically have insulinoma confirmed by pathology (often from EUS-FNB) and are able to provide informed consent.
Who should consider this trial
Good fit: Ideal candidates are people referred to Sahlgrenska with pathology-confirmed pancreatic insulinoma who can understand the procedure and give informed consent.
Not a fit: Patients with severe comorbidity, diffuse or unresectable disease, tumors not reachable by endoscopic ultrasound, or without pathological confirmation are unlikely to benefit.
Why it matters
Potential benefit: If successful, EUS-RFA could offer a less invasive treatment option for insulinoma with fewer complications and faster recovery than conventional surgery.
How similar studies have performed: Small case series and pilot reports have shown EUS-RFA to be technically feasible with symptom improvement for pancreatic neuroendocrine tumors, but large controlled data are limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Gothenburg
- Sahlgrenska Univeristy Hospital — Gothenburg, Sweden (Recruiting)
Study contacts
- Study coordinator: Per Hedenström, Associate Professor
- Email: per.hedenstrom@vgregion.se
- Phone: +46 31 3421000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.