Catheter Placement for Hepatic Hydrothorax
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|ClinicalTrials.gov Identifier: NCT02595567|
Recruitment Status : Unknown
Verified November 2015 by Alexander Chen, Washington University School of Medicine.
Recruitment status was: Recruiting
First Posted : November 3, 2015
Last Update Posted : November 3, 2015
|Condition or disease||Intervention/treatment|
|Pleural Effusion||Device: Indwelling tunneled pleural catheter (ITPC)|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Indwelling Tunneled Catheter Placement for Treatment of Hepatic Hydrothorax|
|Study Start Date :||October 2010|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||September 2016|
Device: Indwelling tunneled pleural catheter (ITPC)
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.
- Requirement for repeated pleural drainage procedures [ Time Frame: Time from catheter placement to catheter removal, an expected average of 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02595567
|Contact: Alexander C Chen, MDemail@example.com|
|Contact: Amy D Bass, RNfirstname.lastname@example.org|
|United States, Missouri|
|St. Louis, Missouri, United States, 63110|
|Contact: Alexander C Chen, MD 314-454-8764 email@example.com|
|Contact: Amy D Bass, RN 314-747-4601 firstname.lastname@example.org|
|Principal Investigator:||Alexander C Chen, MD||Washington University School of Medicine|