Pancreatic Cancer
Conditions
Brief summary
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
DEVICEEndoscopic 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.
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
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants for whom there is technical success of tumor treatment | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with post-procedure complications observed within 30 days | 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 |
| Reduction in the size of the tumor | 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. |
| Reduction in systemic tumor markers | 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 |
Countries
United States
Contacts
CONTACTAmatullah Alibhai, MBA
CONTACTNicole Fatheree, BBA
PRINCIPAL_INVESTIGATORNirav Thosani, MD
The University of Texas Health Science Center at Houston (UTHealth Houston)
Outcome results
None listed