Endoscopic ultrasound-guided radiofrequency ablation for pancreatic and left adrenal lesions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.