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Recruiting NCT07737171

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

— Observational Pancreatic Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Endoscopic Ultrasound (EUS) Guided Radiofrequency Ablation (RFA).
Who it may be relevant to
Registry conditions: Pancreatic Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Safety and Efficacy of Endoscopic Ultrasound (EUS) Guided Radiofrequency Ablation (RFA) in the Treatment of Pancreatic Lesions: A Pancardinal-4 Prospective Registry

Overview

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.

Interventions

  • Device Endoscopic Ultrasound (EUS) Guided Radiofrequency Ablation (RFA)
    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 outcome measures

  • 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]
Secondary outcome measures (3)
  • 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]
  • Reduction in the size of the tumor [Time frame: baseline, 3 months, 6 months, 3 years]
  • 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)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Case-only

Study locations

United States · 1 center
  • The University of Texas Health Science Center at Houston — Houston

Identifiers

NCT: NCT07737171 · HSC-MS-24-1077

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗