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

Malignant Ascites Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01077063
• Other study ID #: J0940
• Secondary ID: Carefusion
• Status: Terminated
• Phase: N/A
• First received: February 25, 2010
• Last updated: October 6, 2015
• Start date: February 2010
• Est. completion date: August 2013

Study information

• Verified date: October 2015
• Source: Sidney Kimmel Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 100 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Ascites
• Malignant Ascites

Intervention

Procedure:
• paracentesis
surgical drainage of malignant ascites

Device:
• Pleurx catheter
take home catheter drainage system that the subject uses himself/herself as needed.

Locations

Country	Name	City	State
United States	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes