An interventional study of Clinical Intervention or Procedure and Electronic Health Record Review in Pancreatic Neoplasm and Pancreatic Neuroendocrine Tumor, sponsored by Ohio State University Comprehensive Cancer Center. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Ohio State University Comprehensive Cancer Center · Not applicable, Interventional, and Treatment
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.
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.
3,896 studies on the registry are indexed under Pancreatic Neoplasms; 1,007 are open to participants now.
This study's planned enrollment of 12 is below the median of 47 across 2,932 interventional studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →Ohio State University Comprehensive Cancer Center is the lead sponsor of 377 studies on the registry; 84 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 19 (50%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
The patient is not a surgical candidate. Common clinical scenarios include -
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients undergo standard of care endoscopic ultrasound-guided fine needle aspiration followed by endoscopic ultrasound-guided pulsed electric field ablation on day 0.
Other: Clinical Intervention or Procedure · Other: Electronic Health Record Review · Procedure: Endoscopic Ultrasound-Guided Fine-Needle Aspiration of the Pancreas · Device: PEF-ablation of pancreatic cyst
Undergo endoscopic ultrasound-guided pulsed electric field ablation
Also known as: Intervention, Intervention or Procedure, Intervention Strategies, Interventional Procedure Type, interventionDescription, Procedure, study intervention, treatment type, treatment_type
Ancillary studies
Undergo endoscopic ultrasound-guided fine needle aspiration
Patients undergo standard of care endoscopic ultrasound-guided fine needle aspiration followed by endoscopic ultrasound-guided pulsed electric field ablation on day 0.
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.
Time frame: 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.
Time frame: At post-procedure and 1 calendar year after endoscopic ultrasound-guided pulsed electric field ablation (EUS-PEF)
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.
Time frame: 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.
Time frame: At 2 and 3 calendar years after EUS-PEF
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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