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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pancreatic Neuroendocrine Tumor; Pancreatic Neoplasm
• Intervention / Treatment: Other: Electronic Health Record Review; Other: Clinical Intervention or Procedure; Procedure: Endoscopic Ultrasound-Guided Fine-Needle Aspiration of the Pancreas

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.

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: The Ohio State University Comprehensive Cancer Center; Phone Number: 800-293-5066; Email: OSUCCCClinicaltrials@osumc.edu

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University Comprehensive Cancer Center
      • Principal Investigator: Somashekar G. Krishna, MD, MPH
      • Contact: Somashekar G. Krishna, MD, MPH; Phone Number: 614-293-6255; Email: somashekar.krishna@osumc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Treatment (EUS-PEF); Patients undergo standard of care endoscopic ultrasound-guided fine needle aspiration followed by endoscopic ultrasound-guided pulsed electric field ablation on day 0.

Other: Electronic Health Record Review; Ancillary studies; Other: Clinical Intervention or Procedure; Undergo endoscopic ultrasound-guided pulsed electric field ablation; Other Names: Intervention; Procedure; Intervention or Procedure; Intervention Strategies; Interventional Procedure Type; interventionDescription; study intervention; treatment type; treatment_type; Procedure: Endoscopic Ultrasound-Guided Fine-Needle Aspiration of the Pancreas; Undergo endoscopic ultrasound-guided fine needle aspiration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of procedure-related adverse events	Incidence, type, and severity of adverse events will be assessed and graded per the American Gastrointestinal Endoscopy Event classification system (and Atlanta Classification for pancreatitis). All adverse events will be collected and tabulated by type, severity, and relationship to the procedure. Results will be reported as counts, rates, and percentages. Where appropriate, 95% confidence intervals for proportions will be provided.	From start of procedure, up to 30 days post procedure
Technical success rate (feasibility)	Defined as successful delivery of pulsed electric field energy to the target pancreatic lesion with completion of the planned ablation protocol, including adequate coverage of the intended lesion and absence of major technical failure. The proportion of cases in which the EUS-PEF procedure is successfully completed (technical feasibility) will be described as a percentage.	At post-procedure and 1 calendar year after endoscopic ultrasound-guided pulsed electric field ablation (EUS-PEF)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of EUS-PEF	Defined as at least a 50% decrease in the lesion diameter. The response will be evaluated by cross-sectional imaging and endoscopic ultrasound (EUS) based on the change in the diameter and/or cyst fluid aspiration (biopsy if there is fibrosis) based on next generation sequencing (NGS) - persistence or absence of mutations (molecular markers) or cytology - results can include either: mucin, atypical/suspicious cells, necrotic material, or inflammatory debris and/or serological changes based on chromogranin A (for cystic-neuroendocrine tumor [NET]) and/or serum cancer antigen (CA) 19-9 (if elevated before intervention). Paired descriptive statistics (mean, median, interquartile range, range) will be reported. Where feasible, exploratory paired nonparametric tests (e.g., Wilcoxon signed-rank test) may be used to assess changes, but these analyses will be interpreted conservatively.	At 1 calendar year after EUS-PEF
Long-term response to EUS-PEF	Defined as at least a 50% decrease in the lesion diameter. Durable response is defined as continued response with further decrease in lesion diameter beyond the first calendar year. The response will be evaluated by cross-sectional imaging and EUS based on the change in the diameter and/or cyst fluid aspiration (biopsy if there is fibrosis) based on NGS - Persistence or absence of mutations (molecular markers) or cytology - results can include either: mucin, atypical/suspicious cells, necrotic material, or inflammatory debris and/or serological changes based on chromogranin A (for cystic-NET) and/or serum CA 19-9 (if elevated before intervention). Paired descriptive statistics (mean, median, interquartile range, range) will be reported. Where feasible, exploratory paired nonparametric tests (e.g., Wilcoxon signed-rank test) may be used to assess changes, but these analyses will be interpreted conservatively.	At 2 and 3 calendar years after EUS-PEF

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center
• Investigators: Principal Investigator: Somashekar G Krishna, MD, MPH, Ohio State University Comprehensive Cancer Center

Publications and helpful links

Helpful Links

• The Jamesline

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: May 27, 2026
• First Submitted That Met QC Criteria: May 27, 2026
• First Posted (Actual): June 2, 2026

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Digestive System Neoplasms; Digestive System Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Neoplasms, Glandular and Epithelial; Adenoma; Pancreatic Neoplasms; Adenoma, Islet Cell; Investigative Techniques; Methods
• Other Study ID Numbers: OSU-25169 (Other Identifier: Ohio State University Comprehensive Cancer Center); NCI-2026-03805 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); STUDY20251089 (Other Identifier: Ohio State University Comprehensive Cancer Center)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No