Endoscopic Ultrasound-Guided Chemoablation for the Treatment of Pancreatic Cystic Neoplasms

PRIMARY OBJECTIVE:

I. To assess the efficacy of EUS-chemoablation of pancreatic cystic neoplasms (PCNs).

SECONDARY OBJECTIVES:

I. To assess the safety of EUS-guided chemoablation of PCNs. II. To assess the long-term response to EUS-chemoablation.

OUTLINE:

Patients undergo EUS-guided fine needle aspiration (FNA) and EUS-guided chemoablation with gemcitabine and paclitaxel via intracystic fine needle injection (FNI) on day 0. Patients also undergo blood and cyst fluid sample collection and magnetic resonance imaging (MRI)/magnetic resonance cholangiopancreatography (MRCP) or computed tomography (CT) throughout the study. Additionally, patients may undergo CT at screening and EUS with or without FNA during follow-up as clinically indicated.

After completion of study treatment, patients are followed every 3-6 or 6-12 months as per standard of care for at least 3 years.

Inclusion criteria

• Age > 18 years
• A diagnosis of a pancreatic cystic neoplasm (PCN) confirmed by endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) including cyst fluid next-generation sequencing (NGS) and/or EUS-needle based confocal laser endomicroscopy (nCLE) and/or EUS-through the needle biopsy (TTNB)
• The pancreatic cystic lesion (PCL) measures at least 1 cm in diameter on CT, MRI/MRCP, or EUS
• This cohort may include patients with PCNs previously treated with other ablative modalities include EUS-radiofrequency ablation (RFA) (NCT05961982, institutional review board [IRB]: 2023C0004) or EUS-pulsed electric field (PEF) (IRB 20251089) who have shown either no response or only a partial response to therapy
• 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
• 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

Exclusion criteria

• Any evidence of severe or uncontrolled systemic diseases or laboratory finding that in the view of the investigator makes it unsafe for the patient to participate in the study
• Any psychiatric disorder making reliable informed consent impossible
• Pregnancy or breast-feeding

• Pregnant patients will be excluded due to confounding variables
• Contraindication to general anesthesia after review by Ohio State University (OSU) Preoperative Assessment Clinic (OPAC)
• Non-English speaking individuals are excluded because study materials, consent forms, and validated patient-reported assessments are available only in English, and interpreter-mediated consent could compromise comprehension of procedural risks associated with an investigational intervention