Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07737171

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

This is a 7-year prospective single-center registry study to assess the safety and efficacy of Endoscopic Ultrasound (EUS) Guided Radiofrequency Ablation (RFA) in the treatment of pancreatic lesions.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

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

Inclusion criteria

  • Diagnosis of any pancreatic pre-malignant lesion and/or pancreatic malignancy
  • Patients already undergoing EUS-RFA for treatment of pancreatic lesions clinically

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

Endoscopic Ultrasound (EUS) Guided Radiofrequency Ablation (RFA)

Device

EUS-guided Radiofrequency Ablation (RFA) consists of the application of alternating current with a frequency of 350-500 kHz (coincidentally the frequency range of radio broadcasts as well) to the target tissue via a special electrode located at the tip of the endoscope.

Primary outcomes

  1. Number of participants for whom there is technical success of tumor treatment

    Time frame: From time of the procedure to about 3 months post procedure

    Technical success of tumor treatment is defined as successful delivery of EUS-guided radiofrequency ablation (RFA) energy to the target pancreatic lesion with:

    • Accurate placement of the RFA probe within the intended lesion under EUS guidance
    • Completion of the planned ablation cycles
    • Immediate post-ablation sonographic evidence of treatment effect (e.g., hyperechoic changes within lesion indicating coagulative necrosis)

Secondary outcomes

  1. Number of participants with post-procedure complications observed within 30 days

    Time frame: from the time of the procedure to 30 days after the procedure

    Post-procedure complications will be defined and graded using the Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.

    Complications will include but are not limited to:

    • Pancreatitis
    • Bleeding
    • Death

  2. Reduction in the size of the tumor

    Time frame: baseline, 3 months, 6 months, 3 years

    Tumor size will be measured using cross-sectional imaging (contrast-enhanced CT or MRI preferred). When clinically indicated, endoscopic ultrasound (EUS) measurements may also be recorded.

  3. Reduction in systemic tumor markers

    Time frame: baseline, at the time of the first RFA (about 1 month after baseline), at the time of the second RFA (about 2 months after baseline), at the time of the third RFA (about 3 month after baseline)

    The following serum markers will be collected:

    • CA 19-9
    • CEA
    • Lipase
    • Amylase

    The following plasma biomarkers will be collected:

    • IL-18
    • ICAM-1
    • CXCL12
    • CD40
    • CD40L
    • TNF-α

Study contacts

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

Amatullah Alibhai, MBA

CONTACT

[email protected]

713-500-6658

Nicole Fatheree, BBA

CONTACT

[email protected]

713-500-5669

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 Pancardinal-4 Prospective Registry

Important dates

Study start
2026
Primary completion
2033
Study completion
2033
First posted
Jul 30, 2026
Registry last updated
Jul 30, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.