Actively Recruiting
Endoscopic Ultrasound-guided Radiofrequency Ablation for Upper Gastrointestinal Tract Lesions - a Prospective Study
Led by Herlev Hospital · Updated on 2025-12-09
138
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the long-term effects of Endoscopic Ultrasound-guided Radiofrequency Ablation (EUS-RFA) in patients with pancreatic or adrenal tumors. This observational study aims to measure clinical improvement in symptoms and biochemical markers, as well as patient satisfaction and quality of life. It also looks at the safety and technical success of the procedure and explores factors linked to outcomes. The study is sponsored by Herlev Hospital and includes patients with benign or small hormone-producing tumors such as insulinomas and Conn syndrome. Participants will receive EUS-RFA as part of their standard care. During the procedure, a fine needle guided by an endoscope and ultrasound delivers radiofrequency energy to heat and destroy tumor cells while sparing nearby tissues. Follow-up includes regular blood tests, imaging scans, and clinical assessments for up to 5 years after treatment. Participants will also complete questionnaires about their satisfaction and quality of life related to their condition. Throughout the study, researchers will monitor clinical effectiveness, patient satisfaction, adverse events, and technical success rates. Data collection will continue until 2040 to assess long-term outcomes, with about 138 patients enrolled between 2025 and 2035. The goal is to determine if EUS-RFA can safely and effectively replace traditional surgery for selected patients, potentially lowering surgical risks and improving recovery and quality of life.
CONDITIONS
Brief 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 fasting test, scanning, and biopsy with low Ki67 index (<10%)
- Non-functional pancreatic neuroendocrine tumors (pNEN) between 10-20 mm that are growing, confirmed by biopsy with low Ki67 index (<10%), or larger pNEN lesions in patients not eligible for surgery
- Unilateral adrenal adenoma (APA) with benign features on non-contrast CT in the left adrenal gland and confirmed lateralization on adrenal vein sampling
- Adult patients able to participate
- Signed informed consent
You will not qualify if you...
- Severe multiple health conditions (ASA score ≥ IV or ECOG score ≥ 4)
- Uncorrected blood clotting problems (INR >1.8 or platelet count < 50 million/L)
- Pregnancy
- Metastatic cancer with expected life expectancy less than 3 years
- Narrowing or altered anatomy of the upper gastrointestinal tract preventing passage of the echoendoscope, such as previous gastrectomy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 week
Participants undergo diagnostic procedures to confirm lesion characteristics and suitability for endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA).
1 to 2 visits depending on lesion assessment
Duration - Up to 5 years
Participants who undergo routine care are observed with ongoing assessments to monitor patient satisfaction, clinical efficacy, adverse events, and technical success.
Regular follow-up visits as part of routine clinical care
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
L
Louise Maegaard, MSc, RN
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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