Catheter Placement for Hepatic Hydrothorax
Condition: Pleural Effusion
MeSH terms: Pleural Effusion; Hydrothorax
Study type: Interventional

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 description: 
      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 patients with HH.
    

Intervention name(s): Indwelling tunneled pleural catheter (ITPC)
Intervention type(s): Device
Intervention description(s): ITPCs have been shown to successfully and safely control dyspnea in patients with malignant pleural effusions. Compared to the large amount of published data regarding the use of indwelling tunneled pleural catheters in malignant effusions, there is a paucity of data regarding the use of ITPC in liver disease for the treatment of hepatic hydrothorax.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Liver disease; Pleural effusion