N/A
N=25
Catheter Placement for Hepatic Hydrothorax
Pleural Effusion
Bottom Line
View on ClinicalTrials.gov: NCT02595567 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
May 2018
Primary outcome: Primary: Feasibility of Using Indwelling Tunneled Pleural Catheters for the Management of Hepatic Hydrothorax — 25 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Indwelling tunneled pleural catheter (ITPC) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Jul 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility of Using Indwelling Tunneled Pleural Catheters for the Management of Hepatic Hydrothorax |
25 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02595567). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.