Clinical trial NCT02119169: Pigtail Catheter: a Less Invasive Option for Pleural Drainage of Recurrent Hepatic Hydrothorax
Official title: Pigtail Catheter: a Less Invasive Option for Pleural Drainage of Recurrent Hepatic Hydrothorax
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pleural Effusion
Lead sponsor: Tanta University
Sponsor class: OTHER
Collaborators: name: Tanta University
First posted: 2014-04-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed 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).

Eligibility criteria: 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%

Primary outcomes:
measure: Change in chest radiography
timeFrame: baseline, daily after treatment within admission
Secondary outcomes:
measure: Chest X-ray and any complications recorded
timeFrame: weekly in first month and monthly for 3 months
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta university hospital
Study officials:
affiliation: TUH
name: Mohamed A. Sharaf-Eldin, professor
role: PRINCIPAL_INVESTIGATOR
affiliation: TUH
name: Adel S Bediwy, Professor
role: STUDY_DIRECTOR
affiliation: TUH
name: Sherief M Abd-Elsalam, Doctor
role: STUDY_CHAIR
affiliation: TUH
name: Abdelrahman a kobtan, doctor
role: STUDY_CHAIR
References:
citation: Sharaf-Eldin M, Bediwy AS, Kobtan A, Abd-Elsalam S, El-Kalla F, Mansour L, Elkhalawany W, Elhendawy M, Soliman S. Pigtail Catheter: A Less Invasive Option for Pleural Drainage in Egyptian Patients with Recurrent Hepatic Hydrothorax. Gastroenterol Res Pract. 2016;2016:4013052. doi: 10.1155/2016/4013052. Epub 2016 Jun 2.