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

NCT06319547 | Recruiting

• 1 other identifier: Soh-Med-24-02-07MS
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Hepatic Hydrothorax

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

hepatic hydrothorax

EXPERIMENTAL

patient with hepatic hydrothorax that develop pleural effusion either unilateral or bilateral

Procedure: Thoracocentasis

Interventions

Thoracocentasis PROCEDURE

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

Also known as: Pigtail Catheter drainage

hepatic hydrothorax

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Liver cirrhosis (with or without hepatocellular carcinoma).
• Hepatic hydrothorax (bilateral or unilateral).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University hospitals

Sohag, Egypt

RECRUITING

Related Publications (4)

• 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.

  PMID: 31129701 BACKGROUND

• 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.

  PMID: 34390708 BACKGROUND

• 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.

  PMID: 34753862 BACKGROUND

• 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.

  PMID: 20708509 BACKGROUND

Central Study Contacts

Aya A AbdElkareem, Resident

CONTACT

01060342951; ayah.ashraf@med.sohag.edu.eg

Khairy H Morsy, Professor

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Tropical medicine and gastroenterology department, Sohag University Hospitals

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: March 20, 2024
• Study Start: February 20, 2024
• Primary Completion: February 1, 2025
• Study Completion: March 1, 2025
• Last Updated: March 20, 2024

Record last verified: 2024-03

Locations

EG (1)