Pancreatic Cyst
Conditions
Brief summary
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.
Interventions
DEVICEEUS-guided RFA treatment
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.
Sponsors
The University of Texas Health Science Center, Houston
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1\. Diagnosis of any pancreatic premalignant lesion and/or pancreatic malignancy
Exclusion criteria
1. Patients with co-existing malignancies of other organs (or a prior history of such) 2. Patients unable to provide informed consent 3. Patients unable to complete follow-up
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Technical Success of EUS-RFA Defined as Complete Ablation of Target Pancreatic Lesions on Imaging | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Serum Tumor Marker Concentrations Following EUS-RFA | 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. |
| Post-procedure complications observed within 30 days | 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. |
| Change in Tumor Size Assessed by Cross-Sectional Imaging | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORNirav C Thosani, MD, MHA
The University of Texas Health Science Center, Houston
Outcome results
None listed