An Early Safety and Efficacy Study of Ascites Management: Standard Paracentesis or Early Intervention With Pleurx Catheters in Patients With Malignant Ascites

This study is currently recruiting participants.

Verified December 2012 by Sidney Kimmel Comprehensive Cancer Center

Sponsor:

Information provided by (Responsible Party):

Sidney Kimmel Comprehensive Cancer Center

ClinicalTrials.gov Identifier:

NCT01077063

First received: February 25, 2010

Last updated: December 11, 2012

Last verified: December 2012

History of Changes

Purpose

The purpose of this study is to assess in a controlled prospective setting, the safety of the use of Pleurx catheters and standard therapeutic paracentesis in patients with malignant ascites.

Condition	Intervention
Malignant Ascites	Procedure: paracentesis Device: Pleurx catheter

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Early Safety and Efficacy Study of Ascites Management: Standard Paracentesis or Early Intervention With Pleurx Catheters in Patients With Malignant Ascites

Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:

Safety of Pleurx catheter or paracentesis [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Primary Outcome: Safety of the Pleurx catheter procedure or paracentesis

Secondary Outcome Measures:

Overall complications, quality of life, overall survival, and symptom control [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Secondary outcomes: Overall complications, quality of life, overall survival, and symptom control

Estimated Enrollment:	30
Study Start Date:	February 2010
Estimated Primary Completion Date:	February 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: paracentesis cutting and draining procedure for malignant ascites	Procedure: paracentesis surgical drainage of malignant ascites
Active Comparator: Pleurx catheter a catheter drainage system the subject uses himself/herself.	Device: Pleurx catheter take home catheter drainage system that the subject uses himself/herself as needed.

Detailed Description:

Study Design: Single institution, open-label, randomized study

Study Device: Pleurx Catheter

Treatment Plan: Cohort A: 15 patients treated with standard therapy (therapeutic paracentesis +/- diuretics)

Cohort B: 15 patients treated with peritoneal Pleurx catheter

Duration of Participation: Patients will be followed for one year, or until death, whichever comes first.

Primary Outcome: Safety of the Pleurx catheter procedure or paracentesis

Secondary outcomes: Overall complications, quality of life, overall survival, and symptom control

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

(Patients can receive chemotherapy at the discretion of treating oncologist)

Patients with recurrent malignant ascites
Patients with refractory malignant ascites
Proven malignancy
Age >= 18 years old
Eastern Cooperative Oncology Group (ECOG) performance scale =< 2
Ability to understand and willingness to sign a written informed consent

Definitions:

Malignant ascites: One of the following criteria

Positive ascitic fluid cytology
Histology proven malignancy with imaging studies with evidence of liver metastasis and ascites
Malignant Budd Chiari Syndrome with associated ascites
Hepatocellular carcinoma and ascites
Chylous ascites due to lymphoma
Peritoneal carcinomatosis and concurrent ascites
Proven abdominal malignancy with concurrent ascites

Refractory / Recurrent ascites: One of the following criteria

Symptomatic ascites that recurred after one paracentesis in a patient with known malignant ascites.
Symptomatic ascites that did not respond clinically to at least two weeks of diuretics. Use of diuretics at the discretion of the treating physician.
Intolerance or relative contraindications to diuretics: (serum sodium (Na) concentration of <125 mmol per liter or serum creatinine >1.5 mg/dl, hyperkalemia (potassium >5.2 mEq/L or azotemia Bun/Creatinine ratio > 20).
Removal of at least 5 L in the preceding two months for symptoms relief

Exclusion criteria:

Life expectancy less than one month
Coagulopathy (international normalized ratio [INR] > 2 that does not correct with fresh frozen plasma)
Hepatorenal syndrome
Active skin infections at abdomen before procedures
Inability to provide inform consent
Platelet counts < 50,000/mcL
Uncontrolled illness including, but not limited to, ongoing or active infection requiring intravenous (IV) antibiotics, that the physician feels would increase the risk of infection with the procedures or white blood cell (WBC) count > 20,000/mcL
Absolute neutrophil count <1000 / cu mm
Pregnant women
Multiloculated ascites

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01077063

Contacts

Contact: Daniel Laheru, MD

410-955-8974

laherda@jhmi.edu

Locations

United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Recruiting
Baltimore, Maryland, United States, 21205-2009
Sub-Investigator: Ana De Jesus, MD
Principal Investigator: Daniel Laheru, MD

Sponsors and Collaborators

Sidney Kimmel Comprehensive Cancer Center

More Information

No publications provided

Responsible Party:	Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:	NCT01077063 History of Changes
Other Study ID Numbers:	J0940, Carefusion
Study First Received:	February 25, 2010
Last Updated:	December 11, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:

Pleurx catheter
malignant ascites

Additional relevant MeSH terms:

Ascites
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013

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