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.
Study Type
OBSERVATIONAL
Enrollment
60
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.
The University of Texas Health Science Center at Houston
Houston, Texas, United States
RECRUITINGNumber of participants for whom there is technical success of tumor treatment
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)
Time frame: From time of the procedure to about 3 months post procedure
Number of participants with post-procedure complications observed within 30 days
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
Time frame: from the time of the procedure to 30 days after the procedure
Reduction in the size of the tumor
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.
Time frame: baseline, 3 months, 6 months, 3 years
Reduction in systemic tumor markers
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
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)
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