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Endoscopic Ultrasound-Guided Pulsed Electric Field Ablation for Pancreatic Neoplasms

This study is testing a new, minimally invasive treatment called endoscopic ultrasound-guided pulsed electric field ablation for pancreatic neoplasms (abnormal growths in the pancreas). This treatment uses brief bursts of electricity to destroy targeted tissue, like tumors, without using heat. Researchers want to see how safe this procedure is and if it's possible to successfully deliver the treatment. You might be able to join if you are over 18 and have a confirmed diagnosis of certain pancreatic neoplasms, like an intraductal papillary-mucinous neoplasm (IPMN) or a grade I neuroendocrine tumor. The study aims to measure any side effects within 30 days and check the treatment's success up to one year after the procedure. Currently, the study status is unclear, and it plans to enroll 12 participants.

Study design
This is an interventional study planning to enroll 12 participants. It is testing a procedure called endoscopic ultrasound-guided pulsed electric field ablation.
What's involved
You would undergo a standard endoscopic ultrasound-guided fine needle aspiration followed by the endoscopic ultrasound-guided pulsed electric field ablation on day 0. You would then have follow-up visits at 3 and 6 months, and then annually for 3 years.
Compensation
Not stated in the trial record.
Follow-up
Participants are followed for 3 years after the study treatment, with visits at 3 and 6 months, and then annually.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07619417

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

Not Yet Recruiting
NAAges 18+InterventionalTreatment
Ohio State University Comprehensive Cancer Center
~12 participants
Updated 2026-06-02 on ClinicalTrials.gov
What's tested:Clinical Intervention or ProcedureElectronic Health Record ReviewEndoscopic Ultrasound-Guided Fine-Needle Aspiration of the Pancreas

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of procedure-related adverse events
Measured over From start of procedure, up to 30 days post procedure
+1 more outcome measured

Conditions

Pancreatic Neoplasm
Pancreatic Neuroendocrine Tumor

Explore related trials

Pancreatic Cystic LesionPancreatic Intraductal Papillary-Mucinous NeoplasmPancreatic NeoplasmPancreatic Neuroendocrine Tumor

Where it's being run

1 sites across 1 states
Ohio1

Study leadership

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

Who to contact

The Ohio State University Comprehensive Cancer Center
[email protected]
800-293-5066
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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)

What this trial measures

  • Incidence of procedure-related adverse eventsFrom start of procedure, up to 30 days post procedure

    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.

  • Technical success rate (feasibility)At post-procedure and 1 calendar year after endoscopic ultrasound-guided pulsed electric field ablation (EUS-PEF)

    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.