RecruitingNot Applicable

Endoscopic Ultrasound-guided Radiofrequency Ablation for Upper Gastrointestinal Tract Lesions

Denmark138 participantsStarted 2025-11-01

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Patient satisfaction

Timeframe: From enrollment and 5 years forward

Clinical efficacy

Timeframe: From enrollment and 5 years forward

Trial details

NCT IDNCT07272187

SponsorHerlev Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2040-12-31

Contact for this trial

Bojan Kovacevic, ph.d., MD

0045 3868 6312 bojan.kovacevic@regionh.dk

View on ClinicalTrials.gov More Insulinoma; Pancreas trials