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.
Study Type
OBSERVATIONAL
Enrollment
100
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.
Memorial Hermann Hospital
Houston, Texas, United States
Technical success of the tumor treatment
The efficacy of EUS-RFA in inducing the remission of functional, pre-malignant, and/or malignant solid/cystic pancreatic lesions.
Time frame: From the date of patients' index EUS-RFA procedure to the end of their follow-up period at 3 years.
Post-procedure complications observed within 30 days
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.
Time frame: From the date of patients' EUS-RFA procedure to 30 days following the procedure.
Reduction in the size of the tumor
Cross-sectional imaging will be used to evaluate the size of the pancreatic lesions post-RFA treatment. The tumor length, width, and height in centimeters will be assessed. The dimensions of the largest cyst in centimeters (if there are any cystic components) will also be assessed.
Time frame: From the date of patients' index EUS-RFA procedure to the end of their follow-up period at 3 years.
Reduction in systemic tumor markers
Clinically indicated tumor marker assays (CEA, CA 19-9, CA 125, CD40, TNF-α, CD40L) will be analyzed.
Time frame: From the date of patients' index EUS-RFA procedure to the end of their follow-up period at 3 years.
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