Endoscopic Ultrasound-guided Radiofrequency Ablation for Upper Gastrointestinal Tract Lesions

NCT07272187 | Recruiting

• 1 other identifier: p-2025-19131
• Study Type: observational
• Target: 138
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Adverse events

  From enrollment and 5 years forward

• Technical success

  From enrollment and 5 years forward

Other Outcomes (2)

• Factors associated with adverse events

  From enrollment and 5 years forward

• Factors associated with clinical success or failure

  From enrollment and 5 years forward

Study Arms (1)

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

Interventions

observational study OTHER

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

Patients undergoing EUS-RFA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Herlev Hospital: lead

Study Sites (1)

Herlev og Gentofte Hospital

Herlev, Capital Region, 2730, Denmark

RECRUITING

MeSH Terms

Conditions

Insulinoma; Hyperaldosteronism

Interventions

Observation

Condition Hierarchy (Ancestors)

Adenoma, Islet Cell; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Pancreatic Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Adrenocortical Hyperfunction; Adrenal Gland Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Bojan Kovacevic, MD, ph.d.

  Herlev and Gentofte Hospital, Capital Region of Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bojan Kovacevic, ph.d., MD

CONTACT

0045 3868 6312; bojan.kovacevic@regionh.dk

Louise Maegaard, MSc, RN

CONTACT

0045 38689879; louise.maegaard@regionh.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: December 9, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): December 31, 2040
• Study Completion (Estimated): December 31, 2041
• Last Updated: December 9, 2025

Record last verified: 2025-11

Locations

DK (1)