Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Neoplasm | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Pancreatic Neuroendocrine Tumor | Pancreatic Neuroendocrine Tumor | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Clinical Intervention or Procedure | Other | — | UNRESOLVED |
| Electronic Health Record Review | Other | — | UNRESOLVED |
| Endoscopic Ultrasound-Guided Fine-Needle Aspiration of the Pancreas | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (EUS-PEF)
- description
- Patients undergo standard of care endoscopic ultrasound-guided fine needle aspiration followed by endoscopic ultrasound-guided pulsed electric field ablation on day 0.
- interventionNames
- Other: Clinical Intervention or Procedure
- Other: Electronic Health Record Review
- Procedure: Endoscopic Ultrasound-Guided Fine-Needle Aspiration of the Pancreas
Primary outcomes (2)
- measure
- Incidence of procedure-related adverse events
- timeFrame
- From start of procedure, up to 30 days post procedure
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available