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Pancreatic NeoplasmNCT07619417

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

A study testing Clinical Intervention or Procedure, Electronic Health Record Review and Endoscopic Ultrasound-Guided Fine-Needle Aspiration of the Pancreas in people with Pancreatic Neoplasm and Pancreatic Neuroendocrine Tumor, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Clinical Intervention or Procedure, Electronic Health Record Review and Endoscopic Ultrasound-Guided Fine-Needle Aspiration of the Pancreas
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteUnited States
Study dates
1 Oct 2027to 31 Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 15Show fewer
  • 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)

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

Other trials in United States

About this study

Official title: 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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. 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:

  1. 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.

Being tested
Clinical Intervention or Procedure, Electronic Health Record Review, Endoscopic Ultrasound-Guided Fine-Needle Aspiration of the Pancreas, PEF-ablation of pancreatic cyst
Medical subject headings
Pancreatic Neoplasms, Adenoma, Islet Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Clinical Intervention or ProcedureOther

    Also called Intervention, Intervention or Procedure, Intervention Strategies, Interventional Procedure Type

    Undergo endoscopic ultrasound-guided pulsed electric field ablation

  • Electronic Health Record ReviewOther

    Ancillary studies

  • Endoscopic Ultrasound-Guided Fine-Needle Aspiration of the PancreasProcedure or surgery

    Undergo endoscopic ultrasound-guided fine needle aspiration

  • PEF-ablation of pancreatic cystDevice

    Patients undergo standard of care endoscopic ultrasound-guided fine needle aspiration followed by endoscopic ultrasound-guided pulsed electric field ablation on day 0.

Study groups in NCT07619417
Study groupRoleWhat they receive
Treatment (EUS-PEF)ExperimentalPatients undergo standard of care endoscopic ultrasound-guided fine needle aspiration followed by endoscopic ultrasound-guided pulsed electric field ablation on day 0.
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From start of procedure, up to 30 days post procedure

  2. 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.

    Measured: At post-procedure and 1 calendar year after endoscopic ultrasound-guided pulsed electric field ablation (EUS-PEF)

Secondary outcomes (2)

  1. 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.

    Measured: At 1 calendar year after EUS-PEF

  2. 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.

    Measured: At 2 and 3 calendar years after EUS-PEF

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2026
  2. Study start1 Oct 2027 (estimated)
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07619417
Sponsor's protocol ID
OSU-25169
Other IDs
NCI-2026-03805, STUDY20251089, OSU-25169
Status last verified
Sep 2026
First submitted
27 May 2026
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Clinical Intervention or Procedure, Electronic Health Record Review and Endoscopic Ultrasound-Guided Fine-Needle Aspiration of the Pancreas in people with Pancreatic Neoplasm and Pancreatic Neuroendocrine Tumor, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of procedure-related adverse events (time frame: From start of procedure, up to 30 days post procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07619417.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.

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