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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
Sponsor:
Information provided by (Responsible Party):
Alexander Chen, Washington University School of Medicine

Brief 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.

Condition or disease Intervention/treatment Phase
Pleural Effusion Device: Indwelling tunneled pleural catheter (ITPC) Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
ITPC 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.




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
United States, Missouri
Washington Universtiy
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Alexander C Chen, MD Washington University School of Medicine

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Alexander Chen, Director Interventional Pulmonolgy, Assistant Professor of Medicine, Division of Pulmonary & Critical Care, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02595567     History of Changes
Other Study ID Numbers: 201108320
First Posted: November 3, 2015    Key Record Dates
Results First Posted: May 8, 2018
Last Update Posted: May 8, 2018
Last Verified: April 2018

Keywords provided by Alexander Chen, Washington University School of Medicine:
Liver disease
Pleural effusion

Additional relevant MeSH terms:
Pleural Effusion
Hydrothorax
Pleural Diseases
Respiratory Tract Diseases