RecruitingNot ApplicableNCT05961982

Evaluation of Endoscopic Ultrasound-Guided Radiofrequency Ablation for the Management of Pancreatic Tumors, ERASE Study

Endoscopic Ultrasound-Guided Radiofrequency Ablation of Pancreatic Cysts - A Safety and Efficacy Trial (ERASE Study)


Sponsor

Ohio State University Comprehensive Cancer Center

Enrollment

84 participants

Start Date

Apr 24, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (called ERASE) is testing whether a procedure called endoscopic ultrasound-guided radiofrequency ablation — where a probe is inserted through the mouth to deliver heat energy directly into a pancreatic cyst or tumor — can safely treat precancerous or cancerous pancreatic lesions without major surgery. **You may be eligible if...** - You are over 18 years old - You have a confirmed diagnosis of a pancreatic cyst or tumor, identified through advanced endoscopic procedures and tissue testing - Your cyst is at least 1.5 cm in size - Your tumor or cyst is considered suitable for this ablation technique **You may NOT be eligible if...** - You have blood clotting problems or are on blood thinners that cannot be safely stopped - Your cyst communicates with the main pancreatic duct - You have a pacemaker or implanted electronic device that could be affected by the procedure - You are pregnant - You have severe medical conditions that make endoscopic procedures unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREChemical Ablation

Undergo EUS-guided chemoablation

PROCEDUREComputed Tomography

Undergo CT

OTHERElectronic Health Record Review

Ancillary studies

PROCEDUREEndoscopic Ultrasound-Guided Fine-Needle Aspiration

Undergo EUS-FNA

PROCEDUREEndoscopic Ultrasound-Guided Radiofrequency Ablation

Undergo EUS-RFA

PROCEDUREMagnetic Resonance Cholangiopancreatography

Undergo MRI/MRCP

PROCEDUREMagnetic Resonance Imaging

Undergo MRI/MRCP


Locations(1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

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NCT05961982


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