Pigtail Catheter: a Less Invasive Option for Pleural Drainage of Recurrent Hepatic Hydrothorax (HH)
Primary Purpose
Pleural Effusion
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Pigtail catheter
Sponsored by
About this trial
This is an interventional treatment trial for Pleural Effusion
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%
Sites / Locations
- Tanta university hospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
pigtail catheter
Arm Description
Pigtail catheter for pleural drainage of recurrent hepatic hydrothorax
Outcomes
Primary Outcome Measures
Change in chest radiography
Secondary Outcome Measures
Chest X-ray and any complications recorded
Full Information
NCT ID
NCT02119169
First Posted
April 14, 2014
Last Updated
December 22, 2017
Sponsor
Sherief Abd-Elsalam
Collaborators
Tanta University
1. Study Identification
Unique Protocol Identification Number
NCT02119169
Brief Title
Pigtail Catheter: a Less Invasive Option for Pleural Drainage of Recurrent Hepatic Hydrothorax
Acronym
HH
Official Title
Pigtail Catheter: a Less Invasive Option for Pleural Drainage of Recurrent Hepatic Hydrothorax
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 2014 (undefined)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sherief Abd-Elsalam
Collaborators
Tanta University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pleural Effusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
pigtail catheter
Arm Type
Experimental
Arm Description
Pigtail catheter for pleural drainage of recurrent hepatic hydrothorax
Intervention Type
Device
Intervention Name(s)
Pigtail catheter
Intervention Description
pigtail catheter for pleural drainage
Primary Outcome Measure Information:
Title
Change in chest radiography
Time Frame
baseline, daily after treatment within admission
Secondary Outcome Measure Information:
Title
Chest X-ray and any complications recorded
Time Frame
weekly in first month and monthly for 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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%
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sherief M Abd-Elsalam, doctor
Phone
00201000040794
Email
Sherif_tropical@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed A. Sharaf-Eldin, professor
Organizational Affiliation
TUH
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Adel S Bediwy, Professor
Organizational Affiliation
TUH
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sherief M Abd-Elsalam, Doctor
Organizational Affiliation
TUH
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Abdelrahman a kobtan, doctor
Organizational Affiliation
TUH
Official's Role
Study Chair
Facility Information:
Facility Name
Tanta university hospital
City
Tanta
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abd-Elsalam
Phone
00201000040794
12. IPD Sharing Statement
Citations:
PubMed Identifier
27340399
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.
Results Reference
derived
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Pigtail Catheter: a Less Invasive Option for Pleural Drainage of Recurrent Hepatic Hydrothorax
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