This phase II trial tests the effect of endoscopic ultrasound (EUS)-guided chemoablation in treating patients with pancreatic cysts. Pancreatic cancer is a fatal disease that is difficult to diagnose at an early stage, and the five-year survival rate is currently less than 10%. Pancreatic cysts are a common precancerous lesion that may develop into pancreatic cancer. An EUS is a procedure in which an endoscope is inserted into the body. An endoscope is a thin, tube-like instrument that has a light and a lens for viewing. A probe at the end of the endoscope is used to bounce high-energy sound waves (ultrasound) off internal organs to make a picture (sonogram). EUS-guided chemoablation uses a fine needle inserted into the pancreatic cyst to deliver chemotherapy, such as gemcitabine and paclitaxel, directly into the cyst ("intracystic"). Gemcitabine is a chemotherapy drug that blocks the cells from making DNA and may kill tumor cells. Paclitaxel is in a class of medications called antimicrotubule agents. It stops tumor cells from growing and dividing and may kill them. An EUS-guided chemoablation, with gemcitabine and paclitaxel, may be an effective minimally invasive strategy to destroy abnormal or precancerous cells while reducing exposure to the rest of the body in patients with pancreatic cysts.
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
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
Single group
Ablation Therapy
Procedure/SurgeryUndergo EUS-guided chemotherapy ablation
Biospecimen Collection
Procedure/SurgeryUndergo blood and cyst fluid sample collection
Computed Tomography
Procedure/SurgeryUndergo CT
Electronic Health Record Review
Other interventionAncillary studies
Endoscopic Ultrasound
Procedure/SurgeryUndergo EUS and EUS-guided chemoablation
Endoscopic Ultrasound-Guided Fine-Needle Aspiration
Procedure/SurgeryUndergo EUS-guided FNA
Gemcitabine Hydrochloride
DrugGiven via EUS-guided intracystic FNI
Magnetic Resonance Cholangiopancreatography
Procedure/SurgeryUndergo MRCP
Magnetic Resonance Imaging
Procedure/SurgeryUndergo MRI
Paclitaxel
DrugGiven via EUS-guided intracystic FNI
Number of participants with greater than 90% reduction in cyst volume
Number of participants with greater than 90% reduction in cyst volume - Determined using standard of care surveillance imaging, magnetic resonance imaging/magnetic resonance cholangiopancreatography (MRI/MRCP), computed tomography (CT) with pancreas protocol, or endoscopic ultrasound (EUS).
Number of participants with > 50% to < 90% reduction in cyst volume
Determined using standard of care surveillance imaging, MRI/MRCP, (or CT with pancreas protocol) or endoscopic ultrasound
Number of participants with < 50% reduction in cyst volume
Determined using standard of care surveillance imaging, MRI/MRCP, (or CT with pancreas protocol) or endoscopic ultrasound
Proportion of adverse events attributable to EUS-chemoablation
Proportion of adverse events attributable to EUS-chemoablation - Will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
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