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

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.

Study Overview

• Status: Terminated
• Conditions: Malignant Ascites
• Intervention / Treatment: Procedure: paracentesis; Device: Pleurx catheter

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

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21205-2009
      • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

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

Definitions:

Malignant ascites: One of the following criteria

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

Refractory / Recurrent ascites: One of the following criteria

1. Symptomatic ascites that recurred after one paracentesis in a patient with known malignant ascites.
2. Symptomatic ascites that did not respond clinically to at least two weeks of diuretics. Use of diuretics at the discretion of the treating physician.
3. 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).
4. Removal of at least 5 L in the preceding two months for symptoms relief

Exclusion criteria:

1. Life expectancy less than one month
2. Coagulopathy (international normalized ratio [INR] > 2 that does not correct with fresh frozen plasma)
3. Hepatorenal syndrome
4. Active skin infections at abdomen before procedures
5. Inability to provide inform consent
6. Platelet counts < 50,000/mcL
7. 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
8. Absolute neutrophil count <1000 / cu mm
9. Pregnant women
10. Multiloculated ascites

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of Pleurx Catheter or Paracentesis	Primary Outcome: Safety of the Pleurx catheter procedure or paracentesis Safety of the pleurx catheter procedure or paracentesis. Safety will be assessed by the degree of unacceptable toxicities, defined as life threatening complications related to the procedure. These include peritonitis, perforation, or death related to the procedure.	3 years

Collaborators and Investigators

• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: February 25, 2010
• First Submitted That Met QC Criteria: February 25, 2010
• First Posted (Estimate): February 26, 2010

Study Record Updates

• Last Update Posted (Estimate): October 29, 2015
• Last Update Submitted That Met QC Criteria: October 6, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: malignant ascites; Pleurx catheter
• Additional Relevant MeSH Terms: Pathologic Processes; Ascites
• Other Study ID Numbers: J0940; Carefusion (Other Grant/Funding Number: Carefusion)