Catheter Placement for Hepatic Hydrothorax

NCT ID: NCT02595567

Last Updated: 2018-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-01
• Study Completion Date: 2015-07-20

Brief Summary

The purpose of this study is to evaluate the effectiveness of an indwelling tunneled pleural catheter (ITPC) in the management of hepatic hydrothorax that is not responsive to conventional medical therapy. Hepatic Hydrothorax (HH) is defined as an accumulation of fluid in the pleural space between the chest wall and the lung and occurs in 5-10% of patients with liver disease. Despite medical therapy with diuretics and salt restriction, many patients still experience intractable, debilitating shortness of breath, often necessitating hospital admission. Repeated thoracentesis,which is a procedure in which the hepatic hydrothorax is drained with a needle may be effective, but is often only temporary prior to the reaccumulation of fluid leading to the requirement of repeated procedures. Trans-jugular intrahepatic porto-systemic shunt (TIPS), while a valuable treatment for HH, is not always effective or able to be performed. Similarly, liver transplantation although potentially curative, is not available to many patients and may be significantly delayed. Many patients do not experience sufficient or timely relief with current conventional therapy.

Detailed Description

Hepatic Hydrothorax (HH) occurs in 5-10% of cirrhotic patients and remains a significant clinical challenge. Despite medical therapy with diuretics and sodium restriction, many patients still experience intractable, debilitating dyspnea and respiratory compromise. Repeated thoracentesis, while often effective, may affect prohibitively transient symptom relief and exposes the patient to repeated procedures with inherent cumulative risk. Trans-jugular intrahepatic porto-systemic shunt (TIPS), while a valuable treatment for HH, is not always effective or able to be performed. Similarly, liver transplantation although potentially curative, is not available to many patients and may be significantly delayed. Many patients do not experience sufficient or timely relief with current conventional therapy. There exists the need for additional therapies, either as a bridge to transplantation or TIPS, or for palliation when transplantation is not expected.

The insertion of an Indwelling tunneled pleural catheters (ITPC) may prove to be safe and effective in treating the dyspnea, cough, and hypoxemia associated with HH in patients refractory to conventional medical management, and serve as an effective bridge to transplantation or TIPS.

ITPCs have been shown to successfully and safely control dyspnea in patients with malignant pleural effusions; producing long-lasting plurodesis in greater than 50% of recipients. Compared to the large amount of published data regarding the use of ITPC in malignant effusions, there is a paucity of data regarding the use of ITPC in benign disease; particularly HH. A small series of four patients and a single case report have previously described the successful use of an ITPC for the management of HH. There exists the need for a prospective study to investigate the potential benefit of using ITPCs in patients with HH.

Conditions

Pleural Effusion

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ITPC

Group Type: OTHER

Indwelling tunneled pleural catheter (ITPC)

Intervention Type: DEVICE

ITPCs have been shown to successfully and safely control dyspnea in patients with malignant pleural effusions. Compared to the large amount of published data regarding the use of indwelling tunneled pleural catheters in malignant effusions, there is a paucity of data regarding the use of ITPC in liver disease for the treatment of hepatic hydrothorax.

Interventions

Indwelling tunneled pleural catheter (ITPC)

ITPCs have been shown to successfully and safely control dyspnea in patients with malignant pleural effusions. Compared to the large amount of published data regarding the use of indwelling tunneled pleural catheters in malignant effusions, there is a paucity of data regarding the use of ITPC in liver disease for the treatment of hepatic hydrothorax.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Subjects who have recurrent pleural effusion due to underlying cirrhosis
• Subjects who are potential candidates for liver transplantation
• Subjects who are candidates for transjugular intrahepatic portosystemic shunt procedures
• Subjects who have had at least one thoracentesis in the past three months

Exclusion Criteria

• Subjects with active bacterial or fungal infection
• Subjectswho are not potential candidates for transplantation
• Subjects with pleural effusions due to processes other than cirrhosis
• Subjects who are critically ill at the time of referral, requiring intensive care unit admission

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Alexander Chen

Director Interventional Pulmonolgy, Assistant Professor of Medicine, Division of Pulmonary & Critical Care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alexander C Chen, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington Universtiy

St Louis, Missouri, United States

Countries

United States

References

Chen A, Massoni J, Jung D, Crippin J. Indwelling Tunneled Pleural Catheters for the Management of Hepatic Hydrothorax. A Pilot Study. Ann Am Thorac Soc. 2016 Jun;13(6):862-6. doi: 10.1513/AnnalsATS.201510-688BC.

Reference Type: DERIVED

PMID: 27015392 (View on PubMed)

Other Identifiers

201108320

Identifier Type: -

Identifier Source: org_study_id