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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ITPC | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indwelling tunneled pleural catheter (ITPC) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Using Indwelling Tunneled Pleural Catheters for the Management of Hepatic Hydrothorax | 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. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexander C Chen, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington Universtiy | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27015392 | Derived | Chen A, Massoni J, Jung D, Crippin J. Indwelling Tunneled Pleural Catheters for the Management of Hepatic Hydrothorax. A Pilot Study. Ann Am Thorac Soc. 2016 Jun;13(6):862-6. doi: 10.1513/AnnalsATS.201510-688BC. |
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| ID | Title | Description |
|---|---|---|
| FG000 | ITPC | Patients in the ITPC (indwelling tunneled pleural catheter) arm will consist of patients with hepatic hydrothorax who have undergone at least one prior thoracentesis which has resulted in improvement in shortness of breath. The fluid characteristics will be consistent with a transudative pleural effusion. Patients in this group will also have been assessed by the Hepatology service and deemed candidates for additional therapy, such as liver transplant, or TIPS (transjugular intrahepatic portosystemic shunt). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | ITPC | Patients in the ITPC (indwelling tunneled pleural catheter) arm will have and ITPC placed for management of recurrent pleural effusion due to liver disease (hepatic hydrothorax). These patients will have undergone at least one prior thoracentesis that has resulted in improvement in shortness of breath. Pleural fluid studies will demonstrate a transudative process, also consistent with hepatic hydrothorax. All patients will have undergone evaluation by the Hepatology service and will have been deemed eligible for additional treatment, such as liver transplant or TIPS (transjugular intrahepatic portosystemic shunt) procedures. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility of Using Indwelling Tunneled Pleural Catheters for the Management of Hepatic Hydrothorax | 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. | Posted | Count of Participants | Participants | 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 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ITPC | Patients in the ITPC (indwelling tunneled pleural catheter) arm will consist of patients with hepatic hydrothorax who have undergone at least one prior thoracentesis which has resulted in improvement in shortness of breath. The fluid characteristics will be consistent with a transudative pleural effusion. Patients in this group will also have been assessed by the Hepatology service and deemed candidates for additional therapy, such as liver transplant, or TIPS (transjugular intrahepatic portosystemic shunt). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alexander Chen, Director of Interventional Pulmonology | Washington University School of Medicine | 314-454-8764 | achen@dom.wustl.edu |
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| ID | Term |
|---|---|
| D010996 | Pleural Effusion |
| D008107 | Liver Diseases |
| ID | Term |
|---|---|
| D010995 | Pleural Diseases |
| D012140 | Respiratory Tract Diseases |
| D004066 | Digestive System Diseases |
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|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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Patients in the ITPC (indwelling tunneled pleural catheter) arm will consist of patients with hepatic hydrothorax who have undergone at least one prior thoracentesis which has resulted in improvement in shortness of breath. The fluid characteristics will be consistent with a transudative pleural effusion. Patients in this group will also have been assessed by the Hepatology service and deemed candidates for additional therapy, such as liver transplant, or TIPS (transjugular intrahepatic portosystemic shunt). |
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| 0 |
| 25 |
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| 25 |
| 0 |
| 25 |
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