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NCT Number: NCT07136324

Safety and Efficacy of EUS-RFA in the Treatment of Pancreatic Lesions: A Prospective Registry

Purpose: The purpose of this registry is to track the clinical outcomes and progression of patients with pancreatic lesions receiving endoscopic ultrasound (EUS)-based radiofrequency ablation (RFA) therapy.

Research Design: This study is a 7-year, single-center prospective registry study with annual follow up. Patients with pancreatic lesions undergoing EUS-guided RFA treatment will be studied. There will be no deviation from standard of care procedures.

Procedures to be Used: Following recruitment into the program, eligible patients will undergo EUS-RFA for the treatment of their pancreatic lesion and/or malignancy as part of their standard of care.

Endoscopic Intervention: The EUS-guided intervention will be performed based on a clinical decision. The data will be collected for research purposes. Briefly, the procedure involves advancing a 19-gauge EUS-RFA catheter into the target lesion under EUS-guidance. RFA energy is then applied in 2-10 cycles with each cycle lasting about 10 to 30 seconds and the power setting ranging from 10 to 30 Watts. The same physician who performs the initial EUS-RFA procedure will be responsible for subsequent EUS-RFA procedures.

Risks and Potential Benefits: This is a minimal-risk study with associated physical risks being those part of routine standard of care. Additional risks associated with this study include the possible loss of confidentiality if the patient data or information is inadvertently disclosed outside of this study, risks associated with obtaining blood samples, and risks associated with obtaining tissue samples via biopsy. However, all information will be kept strictly confidential and will be used only for research purposes by the listed investigators. Patients will not receive any additional benefit from the study aside from those received as part of standard of care.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Pancreatic Cyst Cysts Digestive System Diseases Neoplasms Pancreatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Memorial Hermann Hospital

Houston, Texas, 77054, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of any pancreatic premalignant lesion and/or pancreatic malignancy

Exclusion criteria

  • Patients with co-existing malignancies of other organs (or a prior history of such)
  • Patients unable to provide informed consent
  • Patients unable to complete follow-up

Treatment and study plan

EUS-guided RFA treatment

Device

A 19-gauge EUS-RFA catheter will be inserted into pancreatic lesions under EUS guidance. RFA energy is then applied in 2-10 cycles with each cycle lasting about 10-30 seconds and the power setting ranging from 10-30 Watts.

Primary outcomes

  1. Technical Success of EUS-RFA Defined as Complete Ablation of Target Pancreatic Lesions on Imaging

    Time frame: From the date of patients' index EUS-RFA procedure to the end of their follow-up period at 3 years.

    The efficacy of EUS-RFA in inducing the remission of functional, pre-malignant, and/or malignant solid/cystic pancreatic lesions.

Secondary outcomes

  1. Post-procedure complications observed within 30 days

    Time frame: From the date of patients' EUS-RFA procedure to 30 days following the procedure.

    This will be measured based on the grade of the adverse event (ranging from grade 1 (mild) to grade 5 (death). Some notable adverse events include any deaths, life-threatening complications, congenital anomalies, complications that require intervention to prevent permanent impairment/damage, and hospitalization.

  2. Change in Tumor Size Assessed by Cross-Sectional Imaging

    Time frame: From the date of patients' index EUS-RFA procedure to the end of their follow-up period at 3 years.

    Cross-sectional imaging will be used to assess pancreatic lesion size following EUS-RFA. Tumor length, width, and height will be measured in centimeters. For lesions with cystic components, the maximum cyst diameter in centimeters will also be measured. Change in tumor size will be evaluated from baseline to follow-up.

  3. Change in Serum Tumor Marker Concentrations Following EUS-RFA

    Time frame: From the date of patients' index EUS-RFA procedure to the end of their follow-up period at 3 years.

    Clinically indicated serum tumor marker assays, including CEA, CA 19-9, CA 125, CD40, TNF-α, and CD40L, will be measured at baseline and during follow-up. Change in tumor marker concentrations will be evaluated over the study period.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study title

Safety and Efficacy of Endoscopic Ultrasound (EUS) Guided Radiofrequency Ablation (RFA) in the Treatment of Pancreatic Lesions: A Prospective Registry

Important dates

Study start
2018
Primary completion
2028
Study completion
2028
First posted
Aug 22, 2025
Registry last updated
May 12, 2026

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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