Comparing Outcome of Thoracocentesis and Pigtail Catheter Drainage in Treatment of Patients With Hepatic Hydrothorax

Hepatic Hydrothorax Clinical Trial

Official title:

Comparing Outcome of Thoracocentesis and Pigtail Catheter Drainage in Treatment of Patients With Hepatic Hydrothorax

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06319547
• Other study ID #: Soh-Med-24-02-07MS
• Status: Recruiting
• Phase: N/A
• Start date: February 20, 2024
• Est. completion date: March 2025

Study information

• Verified date: March 2024
• Source: Sohag University
• Contact: Aya A AbdElkareem, Resident
• Phone: 01060342951
• Email: ayah.ashraf[@]med.sohag.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients who met the following inclusion criteria were enrolled:

• Liver cirrhosis (with or without hepatocellular carcinoma).

• Hepatic hydrothorax (bilateral or unilateral).

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Hepatic Hydrothorax
• Hydrothorax

Intervention

Procedure:
• Thoracocentasis
patients will be submitted to diagnostic pleural fluid study, chest x-ray, liver function and blood picture

Locations

Country	Name	City	State
Egypt	Sohag University hospitals	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

Avula 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. — View Citation

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. — View Citation

Gilbert 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. — View Citation

Liu 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 months