Endoscopic Ultrasound-Guided Chemoablation for the Treatment of Pancreatic Cysts

NCT07529483 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: OSU-25163NCI-2026-01895STUDY20250998
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cystic Neoplasm

Outcome Measures

Primary Outcomes (3)

• Number of participants with greater than 90% reduction in cyst volume

  Determined using standard of care surveillance imaging, MRI/MRCP, (or CT with pancreas protocol) or endoscopic ultrasound

  At 12 months after endoscopic ultrasound (EUS)-guided chemoablation

• 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

  At 12 months after EUS-guided chemoablation

• 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

  At 12 months after EUS-guided chemoablation

Secondary Outcomes (1)

• Proportion of adverse events attributable to EUS-chemoablation

  Up to 30 days post procedure

Study Arms (1)

Treatment (EUS-guided chemoablation, gemcitabine, paclitaxel)

EXPERIMENTAL

Patients undergo EUS-guided FNA and EUS-guided chemoablation with gemcitabine and paclitaxel via intracystic FNI on day 0. Patients also undergo blood and cyst fluid sample collection and MRI/MRCP or CT throughout the study. Additionally, patients may undergo CT at screening and EUS with or without FNA during follow-up as clinically indicated.

Procedure: Ablation Therapy; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Other: Electronic Health Record Review; Procedure: Endoscopic Ultrasound; Procedure: Endoscopic Ultrasound-Guided Fine-Needle Aspiration; Drug: Gemcitabine Hydrochloride; Procedure: Magnetic Resonance Cholangiopancreatography; Procedure: Magnetic Resonance Imaging; Drug: Paclitaxel

Interventions

Ablation Therapy PROCEDURE

Undergo EUS-guided chemotherapy ablation

Also known as: Ablation, Ablation, NOS, Catheter Ablation, Local Ablation Therapy, Local Ablative Therapy

Treatment (EUS-guided chemoablation, gemcitabine, paclitaxel)

Computed Tomography PROCEDURE

Undergo CT

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, Diagnostic CAT Scan, Diagnostic CAT Scan Service Type, tomography

Treatment (EUS-guided chemoablation, gemcitabine, paclitaxel)

Endoscopic Ultrasound PROCEDURE

Undergo EUS and EUS-guided chemoablation

Also known as: endosonography, EUS

Treatment (EUS-guided chemoablation, gemcitabine, paclitaxel)

Gemcitabine Hydrochloride DRUG

Given via EUS-guided intracystic FNI

Also known as: dFdCyd, Difluorodeoxycytidine Hydrochloride, Gemcitabine HCI, Gemzar, LY 188011, LY-188011, LY188011

Treatment (EUS-guided chemoablation, gemcitabine, paclitaxel)

Paclitaxel DRUG

Given via EUS-guided intracystic FNI

Also known as: Anzatax, Asotax, Bristaxol, Praxel, Taxol, Taxol Konzentrat

Treatment (EUS-guided chemoablation, gemcitabine, paclitaxel)

Biospecimen Collection PROCEDURE

Undergo blood and cyst fluid sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Treatment (EUS-guided chemoablation, gemcitabine, paclitaxel)

Electronic Health Record Review OTHER

Ancillary studies

Treatment (EUS-guided chemoablation, gemcitabine, paclitaxel)

Endoscopic Ultrasound-Guided Fine-Needle Aspiration PROCEDURE

Undergo EUS-guided FNA

Also known as: endoscopic ultrasound-guided fine needle aspiration, EUS-FNA

Treatment (EUS-guided chemoablation, gemcitabine, paclitaxel)

Magnetic Resonance Cholangiopancreatography PROCEDURE

Undergo MRCP

Also known as: MRCP

Treatment (EUS-guided chemoablation, gemcitabine, paclitaxel)

Magnetic Resonance Imaging PROCEDURE

Undergo MRI

Also known as: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI

Treatment (EUS-guided chemoablation, gemcitabine, paclitaxel)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Links

• The Jamesline

MeSH Terms

Interventions

Catheter Ablation; Specimen Handling; Endoscopic Ultrasound-Guided Fine Needle Aspiration; Gemcitabine; Magnetic Resonance Spectroscopy; Paclitaxel; Taxes

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Biopsy, Fine-Needle; Biopsy, Needle; Biopsy; Cytodiagnosis; Cytological Techniques; Image-Guided Biopsy; Ultrasonography, Interventional; Ultrasonography; Diagnostic Imaging; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Spectrum Analysis; Chemistry Techniques, Analytical; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Economics; Health Care Economics and Organizations

Study Officials

• Somashekar G Krishna, MD, MPH

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

The Ohio State University Comprehensive Cancer Center

CONTACT

800-293-5066; OSUCCCClinicaltrials@osumc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: Independent radiologists, unaware of treatment details, assess cyst resolution on follow-up imaging.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: April 14, 2026
• Study Start (Estimated): June 12, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

US (1)