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

S

Sherief Abd-Elsalam

Status

Unknown

Conditions

Pleural Effusion

Treatments

Device: Pigtail catheter

Study type

Interventional

Funder types

Other

Identifiers

NCT02119169
Mohamed Sharaf-Eldin
Tanta university hospital (Other Grant/Funding Number)

Details and patient eligibility

About

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

Full 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).

Enrollment

30 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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%

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

pigtail catheter
Experimental group
Description:
Pigtail catheter for pleural drainage of recurrent hepatic hydrothorax
Treatment:
Device: Pigtail catheter

Trial contacts and locations

1

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Central trial contact

Sherief M Abd-Elsalam, doctor

Data sourced from clinicaltrials.gov

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