Endoscopic Ultrasound-Guided Chemoablation of Pancreatic Cysts - An Efficacy Trial
Ohio State University Comprehensive Cancer Center
Summary
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.
Description
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 tomogr…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 \…
Interventions
- ProcedureAblation Therapy
Undergo EUS-guided chemotherapy ablation
- ProcedureBiospecimen Collection
Undergo blood and cyst fluid sample collection
- ProcedureComputed Tomography
Undergo CT
- OtherElectronic Health Record Review
Ancillary studies
- ProcedureEndoscopic Ultrasound
Undergo EUS and EUS-guided chemoablation
- ProcedureEndoscopic Ultrasound-Guided Fine-Needle Aspiration
Undergo EUS-guided FNA
- Drug
Location
- Ohio State University Comprehensive Cancer CenterColumbus, Ohio