Thoracoscopic Mesh Repair of Diaphragmatic Defects for Hepatic Hydrothorax

Liver Cirrhosis Clinical Trial

Official title:

Thoracoscopic Mesh Repair of Diaphragmatic Defects for Hepatic Hydrothorax: 10 Years' Experience From a Single Large-volume Center

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02508688
• Other study ID #: 201506012RIND
• Status: Completed
• Phase: N/A
• First received: July 21, 2015
• Last updated: July 27, 2015
• Start date: January 2005
• Est. completion date: June 2015

Study information

• Verified date: July 2015
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

The management of refractory hepatic hydrothorax is challenging and usually unsuccessful. The study will discuss the perioperative treatment, effectiveness, and morphology of diaphragmatic defects of hepatic hydrothorax in thoracoscopic mesh repair. Risk factors associated with increased three-month mortality in these critically ill patients will be studied.

Description:

Objective The objective was to analyze the outcomes of thoracoscopic mesh repair for hepatic hydrothorax (HH) at the institution of the investigators during the past 10 years.

Methods A total of 63 patients with refractory HH, who underwent thoracoscopic mesh onlay reinforcement to repair diaphragmatic defects from January 2005 to December 2014, were included in the study. Mesh covering alone was used in 47 patients and mesh with suturing was used in 16 patients. Patient demographics, Child-Pugh class, and model for end-stage liver disease (MELD) score were evaluated to predict morbidity and mortality.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: June 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• patients with refractory hepatic hydrothorax (> 3 times thoracentesis and failure to maximal doses of diuretics)

Exclusion Criteria:

• Patients with systemic bacteremia, positive culture of bacteria of pleural effusion or ascites were excluded from the study because of potential mesh contamination.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hydrothorax
• Liver Cirrhosis

Intervention

Procedure:
• thoracoscopic diaphragmatic repair
patients with refractory hepatic hydrothorax (> 3 times thoracentesis and failure to maximal doses of diuretics) who underwent thoracoscopic diaphragmatic repair

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	one-month mortality	one-month mortality after thoracoscopic mesh repair	one month	Yes
Primary	three-month mortality	three-month mortality after thoracoscopic mesh repair	three month	Yes
Secondary	recurrence of hepatic hydrothorax	recurrence of hepatic hydrothorax after thoracoscopic mesh repair	20.5 months	Yes

External Links

•   Color Doppler ultrasonography in detecting transdiaphragmatic flow of hepatic hydrothorax: correlation with thoracoscopic findings
•   Effect of the amount of intraoperative fluid administration on postoperative pulmonary complications following anatomic lung resections
•   Hepatic hydrothorax
•   Hepatorenal Disorders
•   Management of refractory hepatic hydrothorax
•   Percutaneous transhepatic biliary drainage complicated with hepatic hydrothorax
•   Symptom recovery after thoracic surgery: Measuring patient-reported outcomes with the MD Anderson Symptom Inventory
•   The morphology of diaphragmatic defects in hepatic hydrothorax: thoracoscopic finding
•   Thoracoscopic diaphragmatic repair for refractory hepatic hydrothorax: application of pleural flap and mesh onlay reinforcement