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

NCT ID: NCT01077063

Last Updated: 2015-10-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2013-08-31

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.

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

Conditions

Malignant Ascites

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

paracentesis

cutting and draining procedure for malignant ascites

Group Type: ACTIVE_COMPARATOR

paracentesis

Intervention Type: PROCEDURE

surgical drainage of malignant ascites

Pleurx catheter

a catheter drainage system the subject uses himself/herself.

Group Type: ACTIVE_COMPARATOR

Pleurx catheter

Intervention Type: DEVICE

take home catheter drainage system that the subject uses himself/herself as needed.

Interventions

paracentesis

surgical drainage of malignant ascites

Intervention Type: PROCEDURE

Pleurx catheter

take home catheter drainage system that the subject uses himself/herself as needed.

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

Carefusion

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

J0940

Identifier Type: -

Identifier Source: org_study_id