Endoscopic Ultrasound-Guided Pulsed Electric Field Ablation of Pancreatic Neoplasms - A Safety and Feasibility Trial
Ohio State University Comprehensive Cancer Center
Summary
This clinical trial tests the safety and feasibility of endoscopic ultrasound-guided pulsed electric field ablation for the treatment of pancreatic neoplasms. Pancreatic cancer is a fatal disease that is difficult to diagnose at an early stage. The approach for pancreatic neoplasm treatment has changed and the recognition of minimally invasive treatments is growing. One such minimally invasive treatment, known as endoscopic ultrasound-guided pulsed electric field ablation, offers an alternative to surgery for managing certain precancerous or high-risk pancreatic cysts. The Aliya Pulsed Electric Field system uses brief, strong bursts of electricity, delivered through a thin needle, to destroy targeted tissue, such as tumors, without using heat. These electric pulses damage only the cells inside the treatment zone, leaving the healthy tissues and important nearby structures unharmed. This makes the treatment safer and less likely to cause harm to sensitive areas around the tumor. Endoscopic ultrasound-guided pulsed electric field ablation may be safe and feasible for the treatment of pancreatic neoplasms.
Description
PRIMARY OBJECTIVE: I. To evaluate the safety of endoscopic ultrasound (EUS)-guided pulsed electric field (PEF) ablation for the treatment of pancreatic neoplasms, measured by the rate and severity of adverse events (graded according to American Gastrointestinal Endoscopy Event \[AGREE\] classification and ATLANTA classification for pancreatitis). SECONDARY OBJECTIVE: I. To determine the feasibility and technical success of using an endoscopic platform to deliver PEF energy for focal ablation of pancreatic neoplasms. OUTLINE: Patients undergo standard of care endoscopic ultrasound-guided f…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age \> 18 years * A diagnosis of a pancreatic neoplasm confirmed by EUS-fine needle aspiration (FNA) - (a) pancreatic cystic lesion such as intraductal papillary-mucinous neoplasm (IPMN), (b) World Health Organization (WHO) grade I neuroendocrine tumor * Lesion size estimation by computed tomography (CT) or magnetic resonance imaging (MRI)/magnetic resonance cholangiopancreatography (MRCP) or EUS: (a) pancreatic cystic lesion such as IPMN - at least 2 cm in diameter. (b) WHO grade I neuroendocrine tumor - at least 1 cm in diameter * The patient is not a surgical candidat…
Interventions
- OtherClinical Intervention or Procedure
Undergo endoscopic ultrasound-guided pulsed electric field ablation
- OtherElectronic Health Record Review
Ancillary studies
- ProcedureEndoscopic Ultrasound-Guided Fine-Needle Aspiration of the Pancreas
Undergo endoscopic ultrasound-guided fine needle aspiration
Location
- Ohio State University Comprehensive Cancer CenterColumbus, Ohio