Endoscopic Ultrasound-Guided Chemoablation for the Treatment of Pancreatic Cystic Neoplasms

Conditions

• Pancreatic Cystic Neoplasm

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date

May 12, 2026

Status verified

May 2026

Primary completion

Dec 31, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

35 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (EUS-guided chemoablation, gemcitabine, paclitaxel)
  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.

Primary Outcome Measure

Number of participants with greater than 90% reduction in cyst volume [ Time Frame: At 12 months after endoscopic ultrasound (EUS)-guided chemoablation ]

Central Contacts

• The Ohio State University Comprehensive Cancer Center
  800-293-5066
  [email protected]

Locations (1)

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