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Endoscopic Ultrasound-guided Radiofrequency Ablation for Upper Gastrointestinal Tract Lesions

Recruitingn/aAges 18 Years - anyAllHerlev Hospital
NCT07272187 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this observational study is to evaluate the long-term clinical effectiveness of EUS-RFA and quality of life in patients with pancreatic or adrenal tumors recieving EUS-RFA. Primary Objectives: * Clinical effectiveness: To evaluate the proportion of included patients who show doc-umented improvement in their clinical symptoms and biochemical parameters (blood test results) over time. * Patient satisfaction: To assess patient satisfaction with the procedure and subsequent disease-related quality of life, measured using validated questionnaires. Secondary Objectives: * Safety: To determine the proportion of treated patients who experience complications, as defined by the AGREE classification, within 30 days after the procedure. * Technical success: To assess the proportion of included patients in whom the EUS-RFA procedure can be successfully completed. Exploratory Objectiv

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📋 Eligibility rules (as published)
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
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What it tests

  • observational study
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Where

1 site
Herlev og Gentofte Hospital
Herlev, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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