search
Back to results

Catheter Placement for Hepatic Hydrothorax

Primary Purpose

Pleural Effusion

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Indwelling tunneled pleural catheter (ITPC)
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pleural Effusion focused on measuring Liver disease, Pleural effusion

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Washington Universtiy

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

ITPC

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 1, 2015
Last Updated
April 5, 2018
Sponsor
Washington University School of Medicine
search

1. Study Identification

Unique Protocol Identification Number
NCT02595567
Brief Title
Catheter Placement for Hepatic Hydrothorax
Official Title
Indwelling Tunneled Catheter Placement for Treatment of Hepatic Hydrothorax
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
October 1, 2010 (Actual)
Primary Completion Date
July 20, 2015 (Actual)
Study Completion Date
July 20, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington University School of Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pleural Effusion
Keywords
Liver disease, Pleural effusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ITPC
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Indwelling tunneled pleural catheter (ITPC)
Intervention Description
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 Measure Information:
Title
Feasibility of Using Indwelling Tunneled Pleural Catheters for the Management of Hepatic Hydrothorax
Description
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.
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander C Chen, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington Universtiy
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27015392
Citation
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.
Results Reference
derived

Learn more about this trial

Catheter Placement for Hepatic Hydrothorax

We'll reach out to this number within 24 hrs