Study on Chemotherapy for Treating Mucinous Pancreatic Cysts

Sponsor: Milton S. Hershey Medical Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03085004

Provider View

This clinical trial is testing a new method to treat pancreatic cysts using chemotherapy. The study compares two approaches: one using an alcohol wash and the other using a saline wash, both followed by chemotherapy drugs paclitaxel and gemcitabine.

Patient Parameters

Program Overview

The aim of this study is to find out if using chemotherapy drugs paclitaxel and gemcitabine can effectively and safely treat pancreatic cysts. The study compares two methods: one involves washing the cyst with alcohol before giving the chemotherapy drugs, and the other uses a saline wash instead. The treatment is delivered using a technique called endoscopic ultrasound guided fine needle infusion (EUS-FNI). This study hopes to find a less invasive way to treat pancreatic cysts, which can sometimes lead to cancer, without the need for surgery or long-term monitoring.

Description

Pancreatic cysts are often found by chance during scans and are more common in older adults. Many of these cysts can potentially turn into pancreatic cancer. Currently, options for dealing with these cysts include regular scans to watch for changes or surgery to remove them, both of which have drawbacks. This study is exploring a new, less invasive treatment using a needle guided by ultrasound to deliver chemotherapy directly to the cysts.

In a previous study, researchers found that using an alcohol wash followed by chemotherapy was effective in shrinking cysts. This new study will test if using a saline wash instead of alcohol is just as effective and safer. Participants will be randomly assigned to one of two groups: one receiving the alcohol wash and the other receiving the saline wash, both followed by the same chemotherapy drugs.

Participants will be monitored closely after the procedure to check for any side effects and to see how well the treatment is working. Follow-up scans will be done at 3, 12, and 24 months to measure the size of the cysts and assess the treatment's success. This study aims to find a safer and more effective way to treat pancreatic cysts and prevent them from becoming cancerous.

Eligibility Criteria

Inclusion Criteria

  • Adults over 18 years old.
  • Have a pancreatic cyst between 2-5 cm in size that is likely mucinous, based on medical guidelines.
  • Able to provide written consent to participate.
  • Can safely undergo an endoscopy with sedation or anesthesia.

Exclusion Criteria

  • Cysts that are likely benign, such as pseudocysts or serous cystadenomas.
  • Known or suspected pancreatic cancer or enlarged lymph nodes.
  • Cysts with high-risk features like large nodules, thick walls, or signs of cancer.
  • Cysts with more than four compartments.
  • Recent acute pancreatitis within the last 6 months.
  • Abnormal lab results, such as very high or low blood cell counts, or high liver enzymes.
  • Any serious medical condition that could interfere with the study or reduce life expectancy.
  • Pregnant, breastfeeding, or incarcerated individuals.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.