Pigtail Catheter: a Less Invasive Option for Pleural Drainage of Recurrent Hepatic Hydrothorax (HH)
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|ClinicalTrials.gov Identifier: NCT02119169|
Recruitment Status : Recruiting
First Posted : April 21, 2014
Last Update Posted : December 27, 2017
|Condition or disease||Intervention/treatment||Phase|
|Pleural Effusion||Device: Pigtail catheter||Not Applicable|
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pigtail Catheter: a Less Invasive Option for Pleural Drainage of Recurrent Hepatic Hydrothorax|
|Study Start Date :||March 2014|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2022|
Experimental: pigtail catheter
Pigtail catheter for pleural drainage of recurrent hepatic hydrothorax
Device: Pigtail catheter
pigtail catheter for pleural drainage
- Change in chest radiography [ Time Frame: baseline, daily after treatment within admission ]
- Chest X-ray and any complications recorded [ Time Frame: weekly in first month and monthly for 3 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02119169
|Contact: Sherief M Abd-Elsalam, doctor||00201000040794||Sherif_tropical@yahoo.com|
|Tanta university hospital||Recruiting|
|Contact: Abd-Elsalam 00201000040794|
|Principal Investigator:||Mohamed A. Sharaf-Eldin, professor||TUH|
|Study Director:||Adel S Bediwy, Professor||TUH|
|Study Chair:||Sherief M Abd-Elsalam, Doctor||TUH|
|Study Chair:||Abdelrahman a kobtan, doctor||TUH|