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

Not Applicable

Terminated

• Conditions: Malignant Ascites
• Interventions: Device: Pleurx catheter; Procedure: paracentesis

• Registration Number: NCT01077063
• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-02-25
• Study First Submitted QC: 2010-02-25
• Study First Posted: 2010-02-26
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Results First Submitted: 2014-09-15
• Results First Submitted QC: 2014-09-15
• Results First Posted: 2014-09-22
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-06
• Last Update Posted: 2015-10-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pleurx catheter	Pleurx catheter	a catheter drainage system the subject uses himself/herself.
paracentesis	paracentesis	cutting and draining procedure for malignant ascites

Primary Outcome Measures

Name	Time	Method
Safety of Pleurx Catheter or Paracentesis	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.

Trial Locations

Locations (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; 🇺🇸 Baltimore, Maryland, United States