Endoscopic Ultrasound-guided Radiofrequency Ablation for Upper Gastrointestinal Tract Lesions

NCT ID: NCT07272187

Last Updated: 2025-12-09

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 138 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-11-01
• Study Completion Date: 2041-12-31

Brief 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.

Conditions

Insulinoma; Pancreas; MEN1; NETs; Radiofrequency Ablation; Endoscopic Ultrasound (EUS); Conn Syndrome

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients undergoing EUS-RFA

The cohort consists of patients with benign pancreatic or adrenal tumors (patients with pNENs, MEN1 and Conns syndrome)

observational study

Intervention Type: OTHER

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

Interventions

observational study

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Herlev Hospital

OTHER

Sponsor Role: lead

Responsible Party

Bojan Kovacevic

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bojan Kovacevic, MD, ph.d.

Role: PRINCIPAL_INVESTIGATOR

Herlev and Gentofte Hospital, Capital Region of Denmark

Locations

Herlev og Gentofte Hospital

Herlev, Capital Region, Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Bojan Kovacevic, ph.d., MD

Role: CONTACT

bojan.kovacevic@regionh.dk

0045 3868 6312

Louise Maegaard, MSc, RN

Role: CONTACT

louise.maegaard@regionh.dk

0045 38689879

Facility Contacts

Bojan Kovacevic, MD, ph.d.

Role: primary

bojan.kovacevic@regionh.dk

0045 38686312

Other Identifiers

p-2025-19131

Identifier Type: -

Identifier Source: org_study_id