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

Pleural Effusion Clinical Trial

— HH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02119169
• Other study ID #: Mohamed Sharaf-Eldin
• Secondary ID: Tanta university
• Status: Recruiting
• Phase: N/A
• First received: April 14, 2014
• Last updated: December 22, 2017
• Start date: March 2014
• Est. completion date: December 2022

Study information

• Verified date: December 2017
• Source: Tanta University
• Contact: Sherief M Abd-Elsalam, doctor
• Phone: 00201000040794
• Email: Sherif_tropical[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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%

Related Conditions & MeSH terms

• Hydrothorax
• Pleural Effusion

Intervention

Device:
• Pigtail catheter
pigtail catheter for pleural drainage

Locations

Country	Name	City	State
Egypt	Tanta university hospital	Tanta

Sponsors (2)

Lead Sponsor	Collaborator
Sherief Abd-Elsalam	Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in chest radiography		baseline, daily after treatment within admission
Secondary	Chest X-ray and any complications recorded		weekly in first month and monthly for 3 months