Endoscopic Ultrasound-guided Radiofrequency Ablation for Upper Gastrointestinal Tract Lesions (EURAGIL)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Radiofrequency Ablation; MEN1; NETs; Insulinoma; Pancreas; Conn Syndrome; Endoscopic Ultrasound (EUS)
• Intervention / Treatment: Other: observational study

• Study Type: Observational
• Enrollment (Estimated): 138

Contacts and Locations

• Study Contact: Name: Bojan Kovacevic, ph.d., MD; Phone Number: 0045 3868 6312; Email: bojan.kovacevic@regionh.dk
• Study Contact Backup: Name: Louise Maegaard, MSc, RN; Phone Number: 0045 38689879; Email: louise.maegaard@regionh.dk

Study Locations

• Denmark
  • Capital Region
    • Herlev, Capital Region, Denmark, 2730
      • Recruiting
      • Herlev og Gentofte Hospital
      • Contact: Bojan Kovacevic, MD, ph.d.; Phone Number: 0045 38686312; Email: bojan.kovacevic@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

All patients who meet the above inclusion criteria will be offered participation. Herlev Hospital has a national function, and therefore patients from all regions of Denmark are included.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients undergoing EUS-RFA; The cohort consists of patients with benign pancreatic or adrenal tumors (patients with pNENs, MEN1 and Conns syndrome)	Other: observational study; Observational study. Patients recieve standard clinical care with routine follow up

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction	Patient satisfaction measured through validated questionarie SF-36. Scores for each domain range from 0 to 100, with a higher score defining a more favorable state	From enrollment and 5 years forward
Clinical efficacy	Proportion of included patients with documented biochemical response and symptom improvement, or lesion size decrement/cessation of growth in case of MEN1 patients	From enrollment and 5 years forward

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Proportion of treated patients experiencing AEs as defined by AGREE classification during a 30-day period following the procedure	From enrollment and 5 years forward
Technical success	Proportion of included patients where EUS-RFA was technically feasible	From enrollment and 5 years forward

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Factors associated with adverse events	Factors associated with adverse events	From enrollment and 5 years forward
Factors associated with clinical success or failure	Factors associated with clinical success or failure	From enrollment and 5 years forward

Collaborators and Investigators

• Sponsor: Herlev Hospital
• Investigators: Principal Investigator: Bojan Kovacevic, MD, ph.d., Herlev and Gentofte Hospital, Capital Region of Denmark

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2025
• Primary Completion (Estimated): December 31, 2040
• Study Completion (Estimated): December 31, 2041

Study Registration Dates

• First Submitted: November 18, 2025
• First Submitted That Met QC Criteria: November 26, 2025
• First Posted (Estimated): December 9, 2025

Study Record Updates

• Last Update Posted (Estimated): December 9, 2025
• Last Update Submitted That Met QC Criteria: November 26, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Digestive System Neoplasms; Digestive System Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Neoplasms, Glandular and Epithelial; Adenoma; Adrenal Gland Diseases; Adrenocortical Hyperfunction; Pancreatic Neoplasms; Adenoma, Islet Cell; Insulinoma; Hyperaldosteronism; Investigative Techniques; Methods; Observation
• Other Study ID Numbers: p-2025-19131

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No