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Pancreatic NeoplasmCancerProcedure

What this study is

This clinical trial evaluates the safety and effectiveness of endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) for the management of patients with pancreatic tumors (including cysts) performed during recommended surveillance endoscopic ultrasound examinations. Pancreatic tumors (cysts) can progress to pancreatic cancer at rate of more than 25% per year risk. Pancreatic cancer is a fatal disease that is difficult to diagnose at an early stage, and the five-year survival rate is currently less than 10%. It is projected to be the second leading cause of cancer-related mortality by the year 2030. A procedure known as radiofrequency ablation may help. Radiofrequency ablation is an established way to treat benign and cancerous tumors in the human body. In the last 5 years, radiofrequency ablation has been applied to treat precancerous tumors (including cysts) in the pancreas. This procedure implements a medical technology that destroys tumors in a much less invasive way compared to traditional surgical removal. By delivering a high-frequency alternating current, radiofrequency ablation uses electrical energy and heat to destroy cancer cells. Radiofrequency ablation is being recognized as a management option in patients with high-risk pancreatic tumors (cysts) but are not deemed surgical candidates. While surgical removal offers a chance of cure, pancreatic surgeries have 20-40% morbidity rate (short and long-term complication) and a 1-2% mortality rate in patients who are surgical candidates. Furthermore, radiofrequency ablation can potentially decrease the need for frequent imaging/surveillance of the pancreatic tumor (cyst). In patients with immediate prohibitive, but reversible risks for surgery, radiofrequency ablation of a high-risk tumors (cysts) can potentially prevent further progression of the lesion and bridge the time before the need for surgical resection.

What's being tested

  • Chemical Ablation

    Intervention · PROCEDURE

    Undergo EUS-guided chemoablation

  • Computed Tomography

    Intervention · PROCEDURE

    Undergo CT

  • Electronic Health Record Review

    Intervention · OTHER

    Ancillary studies

  • Endoscopic Ultrasound-Guided Fine-Needle Aspiration

    Intervention · PROCEDURE

    Undergo EUS-FNA

  • Endoscopic Ultrasound-Guided Radiofrequency Ablation

    Intervention · PROCEDURE

    Undergo EUS-RFA

  • Magnetic Resonance Cholangiopancreatography

    Intervention · PROCEDURE

  • Magnetic Resonance Imaging

    Intervention · PROCEDURE

Both Magnetic Resonance Cholangiopancreatography and Magnetic Resonance Imaging

Undergo MRI/MRCP

Study details

Official title
Endoscopic Ultrasound-Guided Radiofrequency Ablation of Pancreatic Cysts - A Safety and Efficacy Trial (ERASE Study)
Sponsor
Ohio State University Comprehensive Cancer Center
Conditions
Pancreatic Neoplasm
Enrolling
84 people
Starts
2023-04-24
Est. completion
2028-12-31
Design
Open-label, single group
Record
View on ClinicalTrials.gov ↗