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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
Sponsor:
Collaborator:
Tanta University
Information provided by (Responsible Party):
Sherief Abd-Elsalam, Tanta University

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

Condition or disease Intervention/treatment Phase
Pleural Effusion Device: Pigtail catheter Not Applicable

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).


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
Experimental: pigtail catheter
Pigtail catheter for pleural drainage of recurrent hepatic hydrothorax
Device: Pigtail catheter
pigtail catheter for pleural drainage




Primary Outcome Measures :
  1. Change in chest radiography [ Time Frame: baseline, daily after treatment within admission ]

Secondary Outcome Measures :
  1. Chest X-ray and any complications recorded [ Time Frame: weekly in first month and monthly for 3 months ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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%

Information from the National Library of Medicine

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


Contacts
Contact: Sherief M Abd-Elsalam, doctor 00201000040794 Sherif_tropical@yahoo.com

Locations
Egypt
Tanta university hospital Recruiting
Tanta, Egypt
Contact: Abd-Elsalam    00201000040794      
Sponsors and Collaborators
Sherief Abd-Elsalam
Tanta University
Investigators
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sherief Abd-Elsalam, doctor, Tanta University
ClinicalTrials.gov Identifier: NCT02119169     History of Changes
Other Study ID Numbers: Mohamed Sharaf-Eldin
Tanta university hospital ( Other Grant/Funding Number: tanta university hospital )
First Posted: April 21, 2014    Key Record Dates
Last Update Posted: December 27, 2017
Last Verified: December 2017

Additional relevant MeSH terms:
Pleural Effusion
Hydrothorax
Pleural Diseases
Respiratory Tract Diseases