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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


N/A
18 Years
N/A
Open (Enrolling)
Both
Malignant Ascites

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Trial Information

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


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

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety of Pleurx catheter or paracentesis

Outcome Description:

Primary Outcome: Safety of the Pleurx catheter procedure or paracentesis

Outcome Time Frame:

3 years

Safety Issue:

Yes

Authority:

United States: Institutional Review Board

Study ID:

J0940

NCT ID:

NCT01077063

Start Date:

February 2010

Completion Date:

Related Keywords:

  • Malignant Ascites
  • Pleurx catheter
  • malignant ascites
  • Ascites

Name

Location

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410