- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02595567
Catheter Placement for Hepatic Hydrothorax
Indwelling Tunneled Catheter Placement for Treatment of Hepatic Hydrothorax
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Missouri
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Saint Louis, Missouri, United States, 63110
- Washington Universtiy
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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
|
Collaborators and Investigators
Investigators
- Principal Investigator: Alexander C Chen, MD, Washington University School of Medicine
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201108320
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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