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Endoscopic Ultrasound-guided Radiofrequency Ablation for Upper Gastrointestinal Tract Lesions

NCT07272187 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 138

Last updated 2025-12-09

No results posted yet for this study

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

Interventions

OTHER

observational study

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

Sponsors & Collaborators

  • Herlev Hospital

    lead OTHER

Principal Investigators

  • Bojan Kovacevic, MD, ph.d. · Herlev and Gentofte Hospital, Capital Region of Denmark

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-01
Primary Completion
2040-12-31
Completion
2041-12-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07272187 on ClinicalTrials.gov