Hepatic HydrothoraxNCT06319547
Comparing Outcome of Thoracocentesis and Pigtail Catheter Drainage in Treatment of Patients With Hepatic Hydrothorax
A study testing Thoracocentasis in people with Hepatic Hydrothorax, run by Sohag University at 1 site in Egypt.
Trial summary
Hepatic hydrothorax (HH) is a pleural effusion that develops in a patient with cirrhosis and portal hypertension in the absence of cardiopulmonary disease (Lv et al., 2018). Several factors are known to contribute to the development of effusion; the most accepted mechanism of which is the direct delivery of ascitic… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Hepatic Hydrothorax
- What is being tested?
- Thoracocentasis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Feb 2024to Mar 2025
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients who met the following inclusion criteria were enrolled:
- Liver cirrhosis (with or without hepatocellular carcinoma).
- Hepatic hydrothorax (bilateral or unilateral).
Who cannot join
- patients with a pleural effusion due to a condition other than HH.
- who had a diagnosis of tuberculosis pleurisy, parapneumonic effusion, inflammatory pleuritis, other neoplasms, and congestive heart failure.
Trial locations and contacts
1 site in 1 country.
Khairy H Morsy, Professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag University hospitals
Sohag
Magdy M Amin, Professor
About this study
Hepatic hydrothorax (HH) is a pleural effusion that develops in a patient with cirrhosis and portal hypertension in the absence of cardiopulmonary disease (Lv et al., 2018). Several factors are known to contribute to the development of effusion; the most accepted mechanism of which is the direct delivery of ascitic fluid from the peritoneal cavity to the pleural cavity by "positive" intra-abdominal pressure and a "negative" intrathoracic pressure of the pleural cavity through microscopic congenital diaphragmatic defects (Han et al., 2022).
- Conditions
- Hepatic Hydrothorax
- Being tested
- Thoracocentasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThoracocentasisProcedure or surgery
Also called Pigtail Catheter drainage
patients will be submitted to diagnostic pleural fluid study, chest x-ray, liver function and blood picture
| Study group | Role | What they receive |
|---|---|---|
| hepatic hydrothorax | Experimental | patient with hepatic hydrothorax that develop pleural effusion either unilateral or bilateral Receives: Procedure: Thoracocentasis |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of empyema in patients with hepatic hydrothorax after thoracocentesis
Patients with hepatic hydrothorax that undergo repeated thoracocentesis will be monitored for presence of any side effects as empyema
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start20 Feb 2024
- Primary completionFeb 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hepatic HydrothoraxStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Ashraf Abdelkareem, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06319547
- Sponsor's protocol ID
- Soh-Med-24-02-07MS
- Status last verified
- Mar 2024
- First submitted
- 12 Mar 2024
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chaaban T, Kanj N, Bou Akl I. Hepatic Hydrothorax: An Updated Review on a Challenging Disease. Lung. 2019 Aug;197(4):399-405. doi: 10.1007/s00408-019-00231-6. Epub 2019 May 25.
PubMed 31129701Gilbert CR, Shojaee S, Maldonado F, Yarmus LB, Bedawi E, Feller-Kopman D, Rahman NM, Akulian JA, Gorden JA. Pleural Interventions in the Management of Hepatic Hydrothorax. Chest. 2022 Jan;161(1):276-283. doi: 10.1016/j.chest.2021.08.043. Epub 2021 Aug 12.
PubMed 34390708Avula A, Acharya S, Anwar S, Narula N, Chalhoub M, Maroun R, Thapa S, Friedman Y. Indwelling Pleural Catheter (IPC) for the Management of Hepatic Hydrothorax: The Known and the Unknown. J Bronchology Interv Pulmonol. 2022 Jul 1;29(3):179-185. doi: 10.1097/LBR.0000000000000823. Epub 2021 Nov 10.
PubMed 34753862Liu WL, Kuo PH, Ku SC, Huang PM, Yang PC. Impact of therapeutic interventions on survival of patients with hepatic hydrothorax. J Formos Med Assoc. 2010 Aug;109(8):582-8. doi: 10.1016/S0929-6646(10)60095-2.
PubMed 20708509
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Outcome of Thoracocentesis and Pigtail Catheter Drainage in Treatment of Patients With Hepatic Hydrothorax
- ClinicalTrials.gov ID
- NCT06319547
- Acronym / sponsor ID
- Soh-Med-24-02-07MS
- Conditions
- Hepatic Hydrothorax
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 20 Feb 2024 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 20 Mar 2024 (actual)
- 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.
Hepatic hydrothorax (HH) is a pleural effusion that develops in a patient with cirrhosis and portal hypertension in the absence of cardiopulmonary disease (Lv et al., 2018). Several factors are known to contribute to the development of effusion; the most accepted mechanism of which is the direct delivery of ascitic fluid from the peritoneal cavity to the pleural cavity by "positive" intra-abdominal pressure and a "negative" intrathoracic pressure of the pleural cavity through microscopic congenital diaphragmatic defects (Han et al., 2022).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hepatic hydrothorax | Experimental | Procedure: Thoracocentasispatient with hepatic hydrothorax that develop pleural effusion either unilateral or bilateral |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who met the following inclusion criteria were enrolled:
- Liver cirrhosis (with or without hepatocellular carcinoma).
- Hepatic hydrothorax (bilateral or unilateral).
Key exclusion criteria (2 listed)
- patients with a pleural effusion due to a condition other than HH.
- who had a diagnosis of tuberculosis pleurisy, parapneumonic effusion, inflammatory pleuritis, other neoplasms, and congestive heart failure.
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 |
|---|---|---|
| ThoracocentasisAlso: Pigtail Catheter drainagepatients will be submitted to diagnostic pleural fluid study, chest x-ray, liver function and blood picture | Procedure or surgery | hepatic hydrothorax |
Primary outcome
percentage of empyema in patients with hepatic hydrothorax after thoracocentesis
Time frame: 12 months
Patients with hepatic hydrothorax that undergo repeated thoracocentesis will be monitored for presence of any side effects as empyema
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
- Background: PubMed 31129701Chaaban T, Kanj N, Bou Akl I. Hepatic Hydrothorax: An Updated Review on a Challenging Disease. Lung. 2019 Aug;197(4):399-405. doi: 10.1007/s00408-019-00231-6. Epub 2019 May 25.
- Background: PubMed 34390708Gilbert CR, Shojaee S, Maldonado F, Yarmus LB, Bedawi E, Feller-Kopman D, Rahman NM, Akulian JA, Gorden JA. Pleural Interventions in the Management of Hepatic Hydrothorax. Chest. 2022 Jan;161(1):276-283. doi: 10.1016/j.chest.2021.08.043. Epub 2021 Aug 12.
- Background: PubMed 34753862Avula A, Acharya S, Anwar S, Narula N, Chalhoub M, Maroun R, Thapa S, Friedman Y. Indwelling Pleural Catheter (IPC) for the Management of Hepatic Hydrothorax: The Known and the Unknown. J Bronchology Interv Pulmonol. 2022 Jul 1;29(3):179-185. doi: 10.1097/LBR.0000000000000823. Epub 2021 Nov 10.
- Background: PubMed 20708509Liu WL, Kuo PH, Ku SC, Huang PM, Yang PC. Impact of therapeutic interventions on survival of patients with hepatic hydrothorax. J Formos Med Assoc. 2010 Aug;109(8):582-8. doi: 10.1016/S0929-6646(10)60095-2.
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.
Khairy H Morsy, Professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thoracocentasis in people with Hepatic Hydrothorax, run by Sohag University 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 3 inclusion and 2 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 20 Mar 2024. 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 Aya A AbdElkareem, Resident (01060342951, ayah.ashraf@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of empyema in patients with hepatic hydrothorax after thoracocentesis (time frame: 12 months). 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 NCT06319547, which also lists 4 linked publications.
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 20 Mar 2024; AzTrials last refreshed its copy on 8 Nov 2026.