Pigtail Catheter: a Less Invasive Option for Pleural Drainage of Recurrent Hepatic Hydrothorax

Study Overview
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Brief Summary
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The effectiveness of pigtail catheter as a less invasive option for pleural drainage in patients with resistant hepatic hydrothorax.

Detailed Description
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Hepatic hydrothorax (HH) is defined as a transudative pleural effusion in patients with liver cirrhosis in the absence of cardiopulmonary disease. The estimated prevalence among patients with liver cirrhosis is approximately 5-6% (Baikati et al., 2014). HH is an infrequent but a well-known complication of portal hypertension. Trans-diaphragmatic passage of ascitic fluid from peritoneal to the pleural cavity through numerous diaphragmatic defects has been shown to be the predominant mechanism in the formation of HH (Kumar&Kumar, 2014). Patients with hepatic hydrothoraces often have few options (Goto et al., 2011). Diuretic-resistant HH could be managed with liver transplantation, transjugular intrahepatic portosystemic shunt (TIPS) or indwelling pleural catheters. However, tube thoracotomy and pleurodesis failed in most patients (Singh et al., 2013). Case reports and small case series have reported a high rate of complications associated with chest tube placement for hepatic hydrothorax. The most common reported complications were acute kidney injury, pneumothorax, and empyema. Death has been recorded in some cases. Chest tube insertion for hepatic hydrothorax carries significant morbidity and mortality, with questionable benefit (Orman&Lok, 2009). Pigtail catheter insertion is an effective and safe method of draining pleural fluid. Its use is safe and recommended for all cases of pleural effusion requiring chest drain except for empyema and other loculated effusions that yielded low success rate (Bediwy and Amer, 2012).

Official Title
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Pigtail Catheter: a Less Invasive Option for Pleural Drainage of Recurrent Hepatic Hydrothorax

Conditions
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Pleural Effusion

Intervention / Treatment
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* Device: Pigtail catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with cirrhotic liver and recurrent pleural effusion. Pleural fluid should be transudate according to Light's criteria: Pleural fluid-to-serum protein ratio less than 0.5 Pleural fluid lactic dehydrogenase (LDH) less than 200 IU Pleural fluid-to-serum LDH ratio and pleural fluid-to-high normal serum LDH ratio less than 0.6 Exclusion Criteria: Diagnosis of hepatocellular carcinoma or other neoplasm able to shorten life expectancy. Congestive heart failure. Recent (i.e. within the previous 2 weeks) episode of digestive hemorrhage. Exudative pleural effusion. Ascitic fluid or pleural fluid infection Platelet count below 50,000 Prothrombin activity below 50%

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: pigtail catheter<br>Pigtail catheter for pleural drainage of recurrent hepatic hydrothorax | Device: Pigtail catheter<br>* pigtail catheter for pleural drainage<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in chest radiography |  | baseline, daily after treatment within admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chest X-ray and any complications recorded |  | weekly in first month and monthly for 3 months |