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Status unknownNCT02119169HHUpdated Dec 27, 2017

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

An interventional study of Pigtail catheter in Pleural Effusion, sponsored by Sherief Abd-Elsalam. Status unknown at 1 site in Egypt. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-12-27.

Sponsored by Sherief Abd-Elsalam · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
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Study summary

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

Read the 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).

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Conditions studied

  • Pleural Effusion

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03

In context

Pleural Effusion

324 studies on the registry are indexed under Pleural Effusion; 62 are open to participants now.

This study's planned enrollment of 30 is below the median of 63 across 212 interventional studies indexed under Pleural Effusion.

Browse Pleural Effusion studies →

Lead sponsor

Sherief Abd-Elsalam is the lead sponsor of 50 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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%
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    pigtail catheter

    Pigtail catheter for pleural drainage of recurrent hepatic hydrothorax

    Device: Pigtail catheter

Interventions

  • DevicePigtail catheter

    pigtail catheter for pleural drainage

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What researchers measure

Primary outcomes

  1. Change in chest radiography

    Time frame: baseline, daily after treatment within admission

Secondary outcomes

  1. Chest X-ray and any complications recorded

    Time frame: weekly in first month and monthly for 3 months

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Study locations

1 of 1 sites recruiting
  • Tanta university hospital
    Tanta, Egypt
    • Abd-Elsalam · Contact · 00201000040794
    Recruiting
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References and documents

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. PubMed 27340399 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 27, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02119169
Lead sponsor
Sherief Abd-Elsalam
Collaborators
Tanta University
Responsible party
Sherief Abd-Elsalam (doctor, Tanta University) — Sponsor-investigator
First posted
Apr 21, 2014
Start date
Mar 2014
Primary completion
Dec 2022 (estimated)
Completion
Dec 2022 (estimated)
Last update
Dec 27, 2017

Study contacts

Sherief M Abd-Elsalam, doctor
Contact
Sherif_tropical@yahoo.com
00201000040794
Mohamed A. Sharaf-Eldin, professor
principal investigator · TUH
Adel S Bediwy, Professor
study director · TUH
Sherief M Abd-Elsalam, Doctor
study chair · TUH
Abdelrahman a kobtan, doctor
study chair · TUH

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.

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