RecruitingNCT07272187

Endoscopic Ultrasound-guided Radiofrequency Ablation for Upper Gastrointestinal Tract Lesions

Endoscopic Ultrasound-guided Radiofrequency Ablation for Upper Gastrointestinal Tract Lesions - a Prospective Study


Sponsor

Herlev Hospital

Enrollment

138 participants

Start Date

Nov 1, 2025

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating a minimally invasive procedure called endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) — which uses a probe passed down the throat to deliver heat to tumors — for treating small hormone-producing tumors of the pancreas, small non-functioning pancreatic tumors, or certain adrenal gland tumors. **You may be eligible if...** - You have a small insulin-producing pancreatic tumor (insulinoma) of 25mm or less confirmed by fasting and imaging tests - You have a small non-functioning pancreatic neuroendocrine tumor (10–20mm that is growing, or larger if you are not a surgical candidate) - You have a certain type of adrenal gland tumor (unilateral aldosterone-producing adenoma) and are not suitable for surgery **You may NOT be eligible if...** - Your tumor is too large or has spread to other organs - You have a high-grade or aggressive tumor (Ki67 above 10%) - You have a condition preventing safe endoscopy - You are pregnant or unable to give consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

OTHERobservational study

Observational study. Patients recieve standard clinical care with routine follow up


Locations(1)

Herlev og Gentofte Hospital

Herlev, Capital Region, Denmark

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07272187


Related Trials