Endoscopic ultrasound-guided radiofrequency ablation for pancreatic and left adrenal lesions
Endoscopic Ultrasound-guided Radiofrequency Ablation for Upper Gastrointestinal Tract Lesions - a Prospective Study
This will try EUS-guided radiofrequency ablation to control symptoms and hormone-related problems in adults with small pancreatic neuroendocrine tumors (including insulinomas) or certain left adrenal adenomas.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 138 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Herlev Hospital Academic / other |
| Locations | 1 site (Herlev, Capital Region) |
| Trial ID | NCT07272187 on ClinicalTrials.gov |
What this trial studies
EUS-guided radiofrequency ablation (EUS-RFA) uses an echoendoscope to deliver focused thermal energy to lesions in the pancreas or left adrenal through a minimally invasive endoscopic approach. This observational study follows adults who undergo EUS-RFA and collects clinical symptom changes, biochemical test results, and validated quality-of-life and patient satisfaction questionnaires over time. Safety is recorded using the AGREE classification for complications within 30 days, and technical success is documented as the proportion of procedures completed as intended. Exploratory analyses will search for patient- and lesion-level factors associated with adverse events or with clinical and biochemical success.
Who should consider this trial
Good fit: Adults with lesions amenable to EUS-RFA—including insulinomas ≤25 mm confirmed by 72-hour fasting test and biopsy with Ki67 <10%, growing non-functional pNENs 10–20 mm (or larger lesions in patients not fit for surgery), or unilateral left adrenal adenomas localized by AVS—who are able to undergo the procedure and give informed consent.
Not a fit: Patients with severe multimorbidity (ASA ≥ IV or ECOG ≥4), uncorrected coagulopathy, pregnancy, metastatic malignancy with limited life expectancy, or altered upper GI anatomy preventing passage of an echoendoscope are unlikely to benefit.
Why it matters
Potential benefit: If successful, EUS-RFA could provide a less invasive option to reduce hormone secretion and symptoms and potentially avoid or delay surgery.
How similar studies have performed: Small case series and early observational reports show EUS-RFA is technically feasible and can control symptoms for some pancreatic neuroendocrine tumors, but robust long-term outcome data are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* Patients with one or more lesions amendable to undergo EUS-RFA
* Insulinomas ≤ 25 mm confirmed by a 72-h fasting test, cross-sectional scanning, and a biopsy with low Ki67 index (\<10%)
* Non-functional pNEN lesions between 10-20 mm and growing, confirmed by a biopsy with low Ki67 index (\<10%), or larger pNEN lesions in patients who are not candidates for surgical treatment
* Unilateral APA with benign characteristics on non-contrast enhanced CT located in the left adrenal and confirmed lateralization on AVS
* Adult habile patients
* Signed informed consent
Exclusion Criteria:
* Severe multimorbidity (ASA score ≥ IV or ECOG performance score ≥ 4)
* Uncorrected coagulopathy (INR \>1.8 or thrombocyte count \< 50 mia/L)
* Pregnancy
* Metastatic malignancy with expected remaining life expectancy \< 3 years
* Stenosis in upper GI tract or altered anatomy (e.g. previous gastrectomy) preventing the passage of an echoendoscope
Where this trial is running
Herlev, Capital Region
- Herlev og Gentofte Hospital — Herlev, Capital Region, Denmark (Recruiting)
Study contacts
- Principal investigator: Bojan Kovacevic, MD, ph.d. — Herlev and Gentofte Hospital, Capital Region of Denmark
- Study coordinator: Bojan Kovacevic, ph.d., MD
- Email: bojan.kovacevic@regionh.dk
- Phone: 0045 3868 6312
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.