Clinical Trial: Catheter Placement for Hepatic Hydrothorax
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Indwelling Tunneled Catheter Placement for Treatment of Hepatic Hydrothorax
Brief Summary: The purpose of this study is to evaluate the effectiveness of an indwelling tunneled pleural catheter (ITPC) in the management of hepatic hydrothorax that is not responsive to conventional medical therapy. Hepatic Hydrothorax (HH) is defined as an accumulation of fluid in the pleural space between the chest wall and the lung and occurs in 5-10% of patients with liver disease. Despite medical therapy with diuretics and salt restriction, many patients still experience intractable, debilitating shortness of breath, often necessitating hospital admission. Repeated thoracentesis,which is a procedure in which the hepatic hydrothorax is drained with a needle may be effective, but is often only temporary prior to the reaccumulation of fluid leading to the requirement of repeated procedures. Trans-jugular intrahepatic porto-systemic shunt (TIPS), while a valuable treatment for HH, is not always effective or able to be performed. Similarly, liver transplantation although potentially curative, is not available to many patients and may be significantly delayed. Many patients do not experience sufficient or timely relief with current conventional therapy.
Detailed Summary:
Hepatic Hydrothorax (HH) occurs in 5-10% of cirrhotic patients and remains a significant clinical challenge. Despite medical therapy with diuretics and sodium restriction, many patients still experience intractable, debilitating dyspnea and respiratory compromise. Repeated thoracentesis, while often effective, may affect prohibitively transient symptom relief and exposes the patient to repeated procedures with inherent cumulative risk. Trans-jugular intrahepatic porto-systemic shunt (TIPS), while a valuable treatment for HH, is not always effective or able to be performed. Similarly, liver transplantation although potentially curative, is not available to many patients and may be significantly delayed. Many patients do not experience sufficient or timely relief with current conventional therapy. There exists the need for additional therapies, either as a bridge to transplantation or TIPS, or for palliation when transplantation is not expected.
The insertion of an Indwelling tunneled pleural catheters (ITPC) may prove to be safe and effective in treating the dyspnea, cough, and hypoxemia associated with HH in patients refractory to conventional medical management, and serve as an effective bridge to transplantation or TIPS.
ITPCs have been shown to successfully and safely control dyspnea in patients with malignant pleural effusions; producing long-lasting plurodesis in greater than 50% of recipients. Compared to the large amount of published data regarding the use of ITPC in malignant effusions, there is a paucity of data regarding the use of ITPC in benign disease; particularly HH. A small series of four patients and a single case report have previously described the successful use of an ITPC for the management of HH. There exists the need for a prospective study to investigate the potential benefit of using ITPCs in patie
Sponsor: Washington University School of Medicine
Current Primary Outcome: Requirement for repeated pleural drainage procedures [ Time Frame: Time from catheter placement to catheter removal, an expected average of 12 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Washington University School of Medicine
Dates:
Date Received: September 1, 2015
Date Started: October 2010
Date Completion: September 2016
Last Updated: November 2, 2015
Last Verified: November 2015
