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NCT Number: NCT07272187

Endoscopic Ultrasound-guided Radiofrequency Ablation for Upper Gastrointestinal Tract Lesions

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.

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Key information

Conditions

Insulinoma; Pancreas Adenoma Adenoma, Islet Cell Adrenal Gland Diseases Adrenocortical Hyperfunction Conn Syndrome Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Endoscopic Ultrasound (EUS) Hyperaldosteronism Insulinoma MEN1 NETs Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pancreatic Diseases Pancreatic Neoplasms Radiofrequency Ablation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Herlev og Gentofte Hospital

Herlev, Capital Region, 2730, Denmark

Location status: Recruiting

Location contact

Bojan Kovacevic, MD, ph.d.

CONTACT

[email protected]

0045 38686312

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

observational study

Other

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

Primary outcomes

  1. Patient satisfaction

    Time frame: From enrollment and 5 years forward

    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

  2. Clinical efficacy

    Time frame: From enrollment and 5 years forward

    Proportion of included patients with documented biochemical response and symptom improvement, or lesion size decrement/cessation of growth in case of MEN1 patients

Secondary outcomes

  1. Adverse events

    Time frame: From enrollment and 5 years forward

    Proportion of treated patients experiencing AEs as defined by AGREE classification during a 30-day period following the procedure

  2. Technical success

    Time frame: From enrollment and 5 years forward

    Proportion of included patients where EUS-RFA was technically feasible

Other outcomes

  1. Factors associated with adverse events

    Time frame: From enrollment and 5 years forward

    Factors associated with adverse events

  2. Factors associated with clinical success or failure

    Time frame: From enrollment and 5 years forward

    Factors associated with clinical success or failure

Study contacts

Contact information is provided by the study sponsor or research team.

Bojan Kovacevic, ph.d., MD

CONTACT

[email protected]

0045 3868 6312

Louise Maegaard, MSc, RN

CONTACT

[email protected]

0045 38689879

Sponsors and collaborators

Lead sponsor

Herlev Hospital

Other

Registry information

Official study title

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

Acronym: EURAGIL

Important dates

Study start
2025
Primary completion
2040
Study completion
2041
First posted
Dec 9, 2025
Registry last updated
Dec 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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