NCT05961982

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)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVE: I. To assess the efficacy of EUS-RFA of pancreatic cystic neoplasms (PCNs). SECONDARY OBJECTIVES: I. To assess the safety of EUS-guided RFA of PCNs. II. To assess the long-term response to EUS-RFA. OUTLINE: Patients undergo standard of care EUS-fine-needle aspiration (FNA) followed by EUS-RFA on study and may undergo repeat EUS-RFA or EUS-guided chemoablation during surveillance. Patients undergo magnetic resonance imaging (MRI)/magnetic resonance cholangiopancreatography (MRCP), computed tomography (CT), or EUS-FNA at baseline and at follow-up timepoints. After completion of study treatment, patients are followed up every 3-6 months for cysts \>= 3 cm or every 6-12 months for cysts \< 3 cm for up to 3 years.

Conditions

• Pancreatic Neoplasm

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-04-24
• Primary completion: 2027-12-31
• Completion: 2028-12-31
• First posted: 2023-07-27
• Last updated: 2026-03-23

Locations

1 site across 1 country: United States