Pancreatic Cystic Neoplasm
Conditions
Brief 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.
Detailed 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 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.
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
Undergo EUS-guided FNA
DRUGGemcitabine Hydrochloride
Given via EUS-guided intracystic FNI
Undergo MRCP
PROCEDUREMagnetic Resonance Imaging
Undergo MRI
DRUGPaclitaxel
Given via EUS-guided intracystic FNI
Sponsors
Ohio State University Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Independent radiologists, unaware of treatment details, assess cyst resolution on follow-up imaging.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 \[IRB\]: 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with greater than 90% reduction in cyst volume | At 12 months after endoscopic ultrasound (EUS)-guided chemoablation | 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 | At 12 months after EUS-guided chemoablation | 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 | At 12 months after EUS-guided chemoablation | Determined using standard of care surveillance imaging, MRI/MRCP, (or CT with pancreas protocol) or endoscopic ultrasound |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of adverse events attributable to EUS-chemoablation | Up to 30 days post procedure | Proportion of adverse events attributable to EUS-chemoablation - Will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. |
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