Clinical Trial: Impact of Palliative Catheter Placement on the Quality of Life of Patients With Refractory Ascites

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Impact of Palliative Catheter Placement on the Quality of Life of Patients With Refractory Ascites

Brief Summary:

The purpose of this study is look at how treatments for ascites affect quality of life. Your quality of life is the ability for you to enjoy the normal things you do. Ascites (pronounced as-ī-tees) is the presence of extra fluid in the abdomen. Sometimes ascites is caused by cancer, also called malignancy.

All people who participate in this study have ascites associated with cancer. Ascites can cause symptoms that make it difficult for the patient to do simple things. Patients with ascites often report:

Abdominal swelling Difficulty walking. Difficulty breathing. Feeling full when eating. Clothes not fitting due to a swollen abdomen. Swelling in the legs. It is hoped that this catheter will relieve the symptoms of the ascites. The goal of the investigators study is to understand the quality of life before the procedure and after the procedure. Since the patient is having this procedure to make their symptoms better, the investigators want to hear from the patient of how the procedure has affected their quality of life.

Detailed Summary:
Sponsor: Memorial Sloan Kettering Cancer Center

Current Primary Outcome:

• Determine if there is change in the QoL [ Time Frame: 2 years ]
  of patients who have refractory ascites after the placement of a palliative catheter in Interventional Radiology.
• Determine if there is change in symptoms [ Time Frame: 2 years ]
  of patients who have refractory ascites after the placement of a palliative catheter in Interventional Radiology.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Determine the impact ascites has on quality of life [ Time Frame: 2 years ]
  via patient interviews and how this is affected by catheter placement.
• Monitor and describe post-catheter placement morbidity and mortality. [ Time Frame: 2 years ]

Original Secondary Outcome: Same as current

Information By: Memorial Sloan Kettering Cancer Center

Dates:
Date Received: August 24, 2010
Date Started: August 2010
Date Completion: August 2017
Last Updated: September 26, 2016
Last Verified: September 2016