Pancreatic Neoplasm, Pancreatic Neuroendocrine Tumor
Conditions
Brief 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. 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.
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.
Interventions
OTHERClinical Intervention or Procedure
Undergo endoscopic ultrasound-guided pulsed electric field ablation
OTHERElectronic Health Record Review
Ancillary studies
PROCEDUREEndoscopic Ultrasound-Guided Fine-Needle Aspiration of the Pancreas
Undergo endoscopic ultrasound-guided fine needle aspiration
Sponsors
Ohio State University Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of procedure-related adverse events | From 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of EUS-PEF | At 1 calendar year after 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. |
| Long-term response to EUS-PEF | At 2 and 3 calendar years after 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. |
Countries
United States
Contacts
CONTACTThe Ohio State University Comprehensive Cancer Center
PRINCIPAL_INVESTIGATORSomashekar G Krishna, MD, MPH
Ohio State University Comprehensive Cancer Center
Outcome results
None listed