Catheter Placement for Hepatic Hydrothorax
| Status: | Completed |
|---|---|
| Conditions: | Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 5/10/2018 |
| Start Date: | October 1, 2010 |
| End Date: | July 20, 2015 |
Indwelling Tunneled Catheter Placement for Treatment of Hepatic Hydrothorax
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.
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.
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.
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.
Inclusion Criteria:
- Subjects who have recurrent pleural effusion due to underlying cirrhosis
- Subjects who are potential candidates for liver transplantation
- Subjects who are candidates for transjugular intrahepatic portosystemic shunt
procedures
- Subjects who have had at least one thoracentesis in the past three months
Exclusion Criteria:
- Subjects with active bacterial or fungal infection
- Subjectswho are not potential candidates for transplantation
- Subjects with pleural effusions due to processes other than cirrhosis
- Subjects who are critically ill at the time of referral, requiring intensive care unit
admission
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