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

This study has been terminated.
(Study was closed by PI because of low enrollment.)
Sponsor:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01077063
First received: February 25, 2010
Last updated: September 15, 2014
Last verified: September 2014
  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

    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.



Enrollment: 7
Study Start Date: February 2010
Study Completion Date: August 2013
Primary Completion Date: August 2013 (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)

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
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
  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
Results First Received: September 15, 2014
Last Updated: September 15, 2014
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 October 19, 2014