Endoscopic Ultrasound-Guided Pulsed Electric Field Ablation for the Treatment of Pancreatic Neoplasms

Official title

Endoscopic Ultrasound-Guided Pulsed Electric Field Ablation of Pancreatic Neoplasms - A Safety and Feasibility Trial

Overview

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.

Detailed 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 fine needle aspiration followed by endoscopic ultrasound-guided pulsed electric field ablation on day 0.

After completion of study treatment, patients are followed up at 3 and 6 months and then in years 1, 2 and 3.

Interventions

• Other Clinical Intervention or Procedure
  Undergo endoscopic ultrasound-guided pulsed electric field ablation
• Other Electronic Health Record Review
  Ancillary studies
• Procedure Endoscopic Ultrasound-Guided Fine-Needle Aspiration of the Pancreas
  Undergo endoscopic ultrasound-guided fine needle aspiration

Primary outcome measures

• Incidence of procedure-related adverse events [Time frame: From start of procedure, up to 30 days post procedure]
• Technical success rate (feasibility) [Time frame: At post-procedure and 1 calendar year after endoscopic ultrasound-guided pulsed electric field ablation (EUS-PEF)]

Secondary outcome measures (2)

• Efficacy of EUS-PEF [Time frame: At 1 calendar year after EUS-PEF]
• Long-term response to EUS-PEF [Time frame: At 2 and 3 calendar years after EUS-PEF]

Eligibility criteria

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 candidate. Common clinical scenarios include -

• Cirrhosis of the liver (common clinical scenario)
• Advanced (≥ 75 years) age (common clinical scenario)
• Morbid obesity
• Significant cardiorespiratory comorbidity
• Patient's choice (patient elects for non-surgical management)
• Other significant comorbid conditions that impose prohibitive surgical risks
• The patient prefers non-surgical management after consultation with hepato-pancreato-biliary (HPB) surgery
• For pancreatic neuroendocrine tumor (PNET) and all pancreatic cystic lesions (PCLs): Estimated life expectancy of at least 1 year
• Capable of giving written informed consent or has a legally authorized representative (LAR) to consent for them
• Women of childbearing potential must have a negative pregnancy test (serum/urine) on the day of treatment. Pregnancy testing is the routine standard of care practice in the endoscopy laboratory for all patients undergoing endoscopy and sedation for endoscopy
• The patient is not a surgical candidate and has had prior attempts at ablation of the PCN by EUS-RFA (Ohio State University \[OSU\] Institutional Review Board \[IRB\] protocol: 2023C0004)

Exclusion criteria

• Any evidence of severe or uncontrolled systemic diseases, or laboratory findings that, in the investigator's opinion, make it unsafe for the patient to participate in the study study
• Pregnancy or breast-feeding
• Clinical frailty scale
• Contraindication to general anesthesia after review by OSU Preoperative Assessment Clinic (OPAC)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• Ohio State University Comprehensive Cancer Center — Columbus

Identifiers

NCT: NCT07619417 · OSU-25169 · NCI-2026-03805 · STUDY20251089 · OSU-25169

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗