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

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.

Conditions

• Pancreatic Neoplasm

Interventions

PROCEDURE

Chemical Ablation

Undergo EUS-guided chemoablation

PROCEDURE

Computed Tomography

Undergo CT

OTHER

Electronic Health Record Review

Ancillary studies

PROCEDURE

Endoscopic Ultrasound-Guided Fine-Needle Aspiration

Undergo EUS-FNA

PROCEDURE

Endoscopic Ultrasound-Guided Radiofrequency Ablation

Undergo EUS-RFA

PROCEDURE

Magnetic Resonance Cholangiopancreatography

Undergo MRI/MRCP

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI/MRCP

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center

  lead OTHER

Principal Investigators

• Somashekar G Krishna, MD · Ohio State University Comprehensive Cancer Center

Study Design

Allocation

NA

Purpose

PREVENTION

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-04-24

Primary Completion

2027-12-31

Completion

2028-12-31

Countries

• United States

Study Locations