Actively Recruiting
Endoscopic Ultrasound-guided Radiofrequency Ablation for Upper Gastrointestinal Tract Lesions
Led by Herlev Hospital · Updated on 2025-12-09
138
Participants Needed
1
Research Sites
843 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 Objectives: • To identify factors associated with adverse events and factors related to clinical success or lack there of. The study is observational. All participant will receive EUS-RFA as part of their standard clinical care. Participants will: * Undergo EUS-RFA, in which a fine needle is guided into the tumor using an endo-scope and ultrasound imaging. Radiofrequency energy is applied through the needle to heat and destroy tumor cells while protecting the surrounding tissue. * Have follow-up visits including blood tests, imaging scans, and clinical evaluations at regular intervals for up to 5 years after treatment. * Complete validated questionnaires about satisfaction and quality of life. The study will include approximately 138 patients recruited between 2025 and 2035 from two Danish hospital departments (Herlev and Gentofte Hospital and Rigshospitalet). Data collection will continue until 2040 to assess long-term outcomes. This study may help determine whether EUS-RFA can serve as a safe and effective alternative to traditional surgery for selected patients with small hormone-producing or benign tumors in the pancreas or adrenal glands, potentially reducing surgical risks and improving recovery and quality of life.
CONDITIONS
Official Title
Endoscopic Ultrasound-guided Radiofrequency Ablation for Upper Gastrointestinal Tract Lesions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with one or more lesions suitable for EUS-RFA
- Insulinomas 25 mm or smaller confirmed by 72-hour fasting test, imaging, and biopsy with low Ki67 index (<10%)
- Non-functional pancreatic neuroendocrine lesions 10-20 mm and growing, confirmed by biopsy with low Ki67 index (<10%), or larger lesions if surgery is not an option
- Unilateral adrenal adenoma with benign features on CT and confirmed lateralization on adrenal vein sampling
- Adult patients who are medically fit
- Signed informed consent
You will not qualify if you...
- Severe multiple health problems with ASA score 4 or higher or ECOG performance score 4 or higher
- Uncorrected blood clotting problems (INR > 1.8 or platelet count below 50 million/L)
- Pregnancy
- Metastatic cancer with expected survival less than 3 years
- Narrowing or altered upper gastrointestinal anatomy preventing passage of echoendoscope (e.g., previous gastrectomy)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Herlev og Gentofte Hospital
Herlev, Capital Region, Denmark, 2730
Actively Recruiting
Research Team
B
Bojan Kovacevic, ph.d., MD
CONTACT
L
Louise Maegaard, MSc, RN
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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