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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01077063
Recruitment Status : Terminated (Study was closed by PI because of low enrollment.)
First Posted : February 26, 2010
Results First Posted : September 22, 2014
Last Update Posted : October 29, 2015
Sponsor:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Malignant Ascites Procedure: paracentesis Device: Pleurx catheter Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : February 2010
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Safety of Pleurx Catheter or Paracentesis [ Time Frame: 3 years ]

    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.



Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01077063


Locations
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United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21205-2009
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
More Information
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Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT01077063    
Other Study ID Numbers: J0940
Carefusion ( Other Grant/Funding Number: Carefusion )
First Posted: February 26, 2010    Key Record Dates
Results First Posted: September 22, 2014
Last Update Posted: October 29, 2015
Last Verified: October 2015
Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
Pleurx catheter
malignant ascites
Additional relevant MeSH terms:
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Ascites
Pathologic Processes