Trial Outcomes & Findings for Catheter Placement for Hepatic Hydrothorax (NCT NCT02595567)

Results Overview

Feasibility of using ITPC's for the management of hepatic hydrothorax was assessed by the ability of patients to drain pleural effusions routinely via an indwelling tunneled pleural catheter for control of dyspnea related to pleural fluid accumulation. Feasibility was defined as successful catheter placement and improvement in shortness of breath following the procedure. Shortness of breath measurement was descriptive and self reported by patients on routine clinical follow up. Feasibility was also defined as patient ability to drain pleural effusions routinely at home. This was documented by patient logs documenting drainage.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

25 participants

Primary outcome timeframe

From date of ITPC administration until the date of first documented complication such as infection that would require catheter removal or date of pleurodesis, whichever came first, assessed up to 12 months

Results posted on

2018-05-08

Participant Flow

Participant milestones

Participant milestones
Measure	ITPC Patients in the ITPC (indwelling tunneled pleural catheter) arm will consist of patients with hepatic hydrothorax who have undergone at least one prior thoracentesis which has resulted in improvement in shortness of breath. The fluid characteristics will be consistent with a transudative pleural effusion. Patients in this group will also have been assessed by the Hepatology service and deemed candidates for additional therapy, such as liver transplant, or TIPS (transjugular intrahepatic portosystemic shunt).
Overall Study STARTED	25
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ITPC n=25 Participants Patients in the ITPC (indwelling tunneled pleural catheter) arm will have and ITPC placed for management of recurrent pleural effusion due to liver disease (hepatic hydrothorax). These patients will have undergone at least one prior thoracentesis that has resulted in improvement in shortness of breath. Pleural fluid studies will demonstrate a transudative process, also consistent with hepatic hydrothorax. All patients will have undergone evaluation by the Hepatology service and will have been deemed eligible for additional treatment, such as liver transplant or TIPS (transjugular intrahepatic portosystemic shunt) procedures.
Age, Categorical <=18 years	0 Participants n=25 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=25 Participants
Age, Categorical >=65 years	5 Participants n=25 Participants
Age, Continuous	60 Years STANDARD_DEVIATION 1 • n=25 Participants
Sex: Female, Male Female	12 Participants n=25 Participants
Sex: Female, Male Male	13 Participants n=25 Participants
Region of Enrollment United States	25 Participants n=25 Participants

PRIMARY outcome

Timeframe: From date of ITPC administration until the date of first documented complication such as infection that would require catheter removal or date of pleurodesis, whichever came first, assessed up to 12 months

Feasibility of using ITPC's for the management of hepatic hydrothorax was assessed by the ability of patients to drain pleural effusions routinely via an indwelling tunneled pleural catheter for control of dyspnea related to pleural fluid accumulation. Feasibility was defined as successful catheter placement and improvement in shortness of breath following the procedure. Shortness of breath measurement was descriptive and self reported by patients on routine clinical follow up. Feasibility was also defined as patient ability to drain pleural effusions routinely at home. This was documented by patient logs documenting drainage.

Outcome measures

Outcome measures
Measure	ITPC n=25 Participants Patients in the ITPC (indwelling tunneled pleural catheter) arm will consist of patients with hepatic hydrothorax who have undergone at least one prior thoracentesis which has resulted in improvement in shortness of breath. The fluid characteristics will be consistent with a transudative pleural effusion. Patients in this group will also have been assessed by the Hepatology service and deemed candidates for additional therapy, such as liver transplant, or TIPS (transjugular intrahepatic portosystemic shunt).
Feasibility of Using Indwelling Tunneled Pleural Catheters for the Management of Hepatic Hydrothorax	25 Participants

Adverse Events

ITPC

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Alexander Chen, Director of Interventional Pulmonology

Washington University School of Medicine

Phone: 314-454-8764

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place