Catheter Placement for Hepatic Hydrothorax
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|ClinicalTrials.gov Identifier: NCT02595567|
Recruitment Status : Completed
First Posted : November 3, 2015
Results First Posted : May 8, 2018
Last Update Posted : May 8, 2018
|Condition or disease||Intervention/treatment||Phase|
|Pleural Effusion||Device: Indwelling tunneled pleural catheter (ITPC)||Not Applicable|
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)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Indwelling Tunneled Catheter Placement for Treatment of Hepatic Hydrothorax|
|Actual Study Start Date :||October 1, 2010|
|Actual Primary Completion Date :||July 20, 2015|
|Actual Study Completion Date :||July 20, 2015|
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.
- Feasibility of Using Indwelling Tunneled Pleural Catheters for the Management of Hepatic Hydrothorax [ Time Frame: From date of ITPC administration until the date of first documented complication such as infection that would require catheter removal or date of pleurodesis, whichever came first, assessed up to 12 months ]Feasibility of using ITPC's for the management of hepatic hydrothorax was assessed by the ability of patients to drain pleural effusions routinely via an indwelling tunneled pleural catheter for control of dyspnea related to pleural fluid accumulation. Feasibility was defined as successful catheter placement and improvement in shortness of breath following the procedure. Shortness of breath measurement was descriptive and self reported by patients on routine clinical follow up. Feasibility was also defined as patient ability to drain pleural effusions routinely at home. This was documented by patient logs documenting drainage.
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
|United States, Missouri|
|Saint Louis, Missouri, United States, 63110|
|Principal Investigator:||Alexander C Chen, MD||Washington University School of Medicine|