Pigtail Catheter: a Less Invasive Option for Pleural Drainage of Recurrent Hepatic Hydrothorax
HH
2 other identifiers
interventional
30
1 country
1
Brief Summary
The effectiveness of pigtail catheter as a less invasive option for pleural drainage in patients with resistant hepatic hydrothorax.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 14, 2014
CompletedFirst Posted
Study publicly available on registry
April 21, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedDecember 27, 2017
December 1, 2017
8.8 years
April 14, 2014
December 22, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Change in chest radiography
baseline, daily after treatment within admission
Secondary Outcomes (1)
Chest X-ray and any complications recorded
weekly in first month and monthly for 3 months
Study Arms (1)
pigtail catheter
EXPERIMENTALPigtail catheter for pleural drainage of recurrent hepatic hydrothorax
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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%
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sherief Abd-Elsalamlead
- Tanta Universitycollaborator
Study Sites (1)
Tanta university hospital
Tanta, Egypt
Related Publications (1)
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.
PMID: 27340399DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- doctor
Study Record Dates
First Submitted
April 14, 2014
First Posted
April 21, 2014
Study Start
March 1, 2014
Primary Completion
December 1, 2022
Study Completion
December 1, 2022
Last Updated
December 27, 2017
Record last verified: 2017-12