Pleural EffusionHHNCT02119169
Pigtail Catheter: a Less Invasive Option for Pleural Drainage of Recurrent Hepatic Hydrothorax
A study testing Pigtail catheter in people with Pleural Effusion, run by Sherief Abd-Elsalam at 1 site in Egypt.
Trial summary
The effectiveness of pigtail catheter as a less invasive option for pleural drainage in patients with resistant hepatic hydrothorax. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pleural Effusion
- What is being tested?
- Pigtail catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2014to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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%
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Tanta university hospital
Tanta
Abd-Elsalam, 00201000040794
About this study
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).
- Conditions
- Pleural Effusion
- Being tested
- Pigtail catheter
- Medical subject headings
- Pleural Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pigtail catheterDevice
pigtail catheter for pleural drainage
| Study group | Role | What they receive |
|---|---|---|
| pigtail catheter | Experimental | Pigtail catheter for pleural drainage of recurrent hepatic hydrothorax Receives: Device: Pigtail catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in chest radiography
Measured: baseline, daily after treatment within admission
Secondary outcomes (1)
Chest X-ray and any complications recorded
Measured: weekly in first month and monthly for 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2014 (estimated)
- Study startMar 2014
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pleural EffusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sherief Abd-Elsalam
- Sponsor type
- University, hospital or other
- Collaborators
- Tanta University
- Responsible party
- Sponsor-investigator, Sherief Abd-Elsalam, Tanta University
- Investigators
- Mohamed A. Sharaf-Eldin, professor, Principal investigator, TUHAdel S Bediwy, Professor, Study director, TUHSherief M Abd-Elsalam, Doctor, Study chair, TUHAbdelrahman a kobtan, doctor, Study chair, TUH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02119169
- Sponsor's protocol ID
- Mohamed Sharaf-Eldin
- Other IDs
- Tanta university hospital
- Acronym
- HH
- Status last verified
- Dec 2017
- First submitted
- 14 Apr 2014
- Last updated
- 27 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pigtail Catheter: a Less Invasive Option for Pleural Drainage of Recurrent Hepatic Hydrothorax
- ClinicalTrials.gov ID
- NCT02119169
- Acronym / sponsor ID
- HH / Mohamed Sharaf-Eldin
- Conditions
- Pleural Effusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sherief Abd-ElsalamUniversity, hospital or other
- Collaborators
- Tanta University
- Study start
- Mar 2014
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 21 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pigtail catheter | Experimental | Device: Pigtail catheterPigtail catheter for pleural drainage of recurrent hepatic hydrothorax |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with cirrhotic liver and recurrent pleural effusion.
- Pleural fluid should be transudate according to Light's criteria:
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pigtail catheterpigtail catheter for pleural drainage | Device | pigtail catheter |
Primary outcome
Change in chest radiography
Time frame: baseline, daily after treatment within admission
1 secondary outcome
Chest X-ray and any complications recorded
Time frame: weekly in first month and monthly for 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2017.
- Derived from this study: PubMed 27340399Sharaf-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed A. Sharaf-Eldin, professor principal investigator
TUH
Adel S Bediwy, Professor study director
TUH
Sherief M Abd-Elsalam, Doctor study chair
TUH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pigtail catheter in people with Pleural Effusion, run by Sherief Abd-Elsalam at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sherief M Abd-Elsalam, doctor (00201000040794, Sherif_tropical@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in chest radiography (time frame: baseline, daily after treatment within admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02119169, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2017.