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NCT07529483

PHASE2

Endoscopic Ultrasound-Guided Chemoablation for the Treatment of Pancreatic Cysts

Sponsor: Ohio State University Comprehensive Cancer Center

View on ClinicalTrials.gov

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.

Official title: Endoscopic Ultrasound-Guided Chemoablation of Pancreatic Cysts - An Efficacy Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-06-12

Completion Date

2027-12-31

Last Updated

2026-04-14

Healthy Volunteers

Conditions

Pancreatic Cystic Neoplasm

Interventions

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

Inclusion Criteria: * Age \> 18 years * A diagnosis of a PCN confirmed by 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

Locations (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Clinical Research Directory

Endoscopic Ultrasound-Guided Chemoablation for the Treatment of Pancreatic Cysts

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (1)