NCT07529483

Endoscopic Ultrasound-Guided Chemoablation for the Treatment of Pancreatic Cysts

Endoscopic Ultrasound-Guided Chemoablation of Pancreatic Cysts - An Efficacy Trial

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pancreatic Cystic Neoplasm

Interventions

Type	Name	Description
PROCEDURE	Ablation Therapy	Undergo EUS-guided chemotherapy ablation
PROCEDURE	Biospecimen Collection	Undergo blood and cyst fluid sample collection
PROCEDURE	Computed Tomography	Undergo CT
OTHER	Electronic Health Record Review	Ancillary studies
PROCEDURE	Endoscopic Ultrasound	Undergo EUS and EUS-guided chemoablation
PROCEDURE	Endoscopic Ultrasound-Guided Fine-Needle Aspiration	Undergo EUS-guided FNA
DRUG	Gemcitabine Hydrochloride	Given via EUS-guided intracystic FNI
PROCEDURE	Magnetic Resonance Cholangiopancreatography	Undergo MRCP
PROCEDURE	Magnetic Resonance Imaging	Undergo MRI
DRUG	Paclitaxel	Given via EUS-guided intracystic FNI

Timeline

• Start date: 2026-06-12
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2026-04-14
• Last updated: 2026-04-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study