Study on Using Endoscopic Ultrasound-Guided Chemoablation for Treating Pancreatic Cysts

Sponsor: Ohio State University Comprehensive Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT07529483

Provider View

This clinical trial is exploring a new method called endoscopic ultrasound-guided chemoablation to treat pancreatic cysts, which can potentially develop into pancreatic cancer. The study aims to see if this approach can effectively destroy abnormal cells in the cysts while minimizing exposure to the rest of the body.

Patient Parameters

Program Overview

This study is testing a new treatment method for pancreatic cysts, which are growths that can sometimes turn into cancer. The treatment uses a procedure called endoscopic ultrasound (EUS) to guide a fine needle into the cyst and deliver chemotherapy drugs directly into it. This method, known as chemoablation, uses drugs like gemcitabine and paclitaxel to target and destroy abnormal cells in the cyst. The goal is to see if this approach can effectively treat the cysts while reducing the risk of affecting other parts of the body.

Description

The main goal of this study is to see how well endoscopic ultrasound-guided chemoablation works in treating pancreatic cysts. Researchers also want to ensure that this treatment is safe and to understand how long the effects last.

In this study, patients will undergo a procedure where a fine needle is used to inject chemotherapy drugs directly into the pancreatic cyst. This is done using an endoscope, a thin tube with a camera and light, to guide the needle. Patients will also have blood and cyst fluid samples taken and undergo imaging tests like MRI or CT scans throughout the study.

After the treatment, patients will be monitored regularly every 3 to 12 months for at least three years to check on their health and the treatment's effectiveness.

Eligibility Criteria

Inclusion Criteria

  • Must be over 18 years old.
  • Have a confirmed diagnosis of a pancreatic cystic neoplasm (PCN) through specific medical tests.
  • The cyst must be at least 1 cm in size as seen on imaging tests.
  • May include patients who have tried other treatments for their cysts but did not fully respond.
  • Not suitable for surgery due to reasons like liver disease, advanced age, obesity, heart or lung issues, personal choice, or other health conditions.
  • Expected to live at least one more year.
  • Able to give written consent or have a representative do so.
  • Women who can have children must test negative for pregnancy on the day of treatment.

Exclusion Criteria

  • Have severe or uncontrolled health issues that make participating unsafe.
  • Have a psychiatric disorder that prevents giving informed consent.
  • Are pregnant or breastfeeding.
  • Cannot undergo general anesthesia safely.
  • Do not speak English, as study materials are only available in English.

Locations

FACILITYZIPCITYSTATE
Ohio State University Comprehensive Cancer Center43210ColumbusOhio

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