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

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

Study Overview

• Status: Unknown
• Conditions: Pleural Effusion
• Intervention / Treatment: Device: Pigtail catheter

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
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sherief M Abd-Elsalam, doctor; Phone Number: 00201000040794; Email: Sherif_tropical@yahoo.com

Study Locations

• Egypt
  • Tanta, Egypt
    • Recruiting
    • Tanta University Hospital
    • Contact: Abd-Elsalam; Phone Number: 00201000040794

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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%

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: pigtail catheter; Pigtail catheter for pleural drainage of recurrent hepatic hydrothorax	Device: Pigtail catheter; pigtail catheter for pleural drainage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in chest radiography	baseline, daily after treatment within admission

Secondary Outcome Measures

Outcome Measure	Time Frame
Chest X-ray and any complications recorded	weekly in first month and monthly for 3 months

Collaborators and Investigators

• Sponsor: Sherief Abd-Elsalam
• Collaborators: 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 and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: April 14, 2014
• First Submitted That Met QC Criteria: April 18, 2014
• First Posted (Estimate): April 21, 2014

Study Record Updates

• Last Update Posted (Actual): December 27, 2017
• Last Update Submitted That Met QC Criteria: December 22, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Pleural Diseases; Pleural Effusion; Hydrothorax
• Other Study ID Numbers: Mohamed Sharaf-Eldin; Tanta university hospital (Other Grant/Funding Number: tanta university hospital)