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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

Primary Purpose

Malignant Ascites

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

paracentesis

Pleurx catheter

About this trial

This is an interventional treatment trial for Malignant Ascites focused on measuring Pleurx catheter, malignant ascites

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

(Patients can receive chemotherapy at the discretion of treating oncologist)

Patients with recurrent malignant ascites
Patients with refractory malignant ascites
Proven malignancy
Age >= 18 years old
Eastern Cooperative Oncology Group (ECOG) performance scale =< 2
Ability to understand and willingness to sign a written informed consent

Definitions:

Malignant ascites: One of the following criteria

Positive ascitic fluid cytology
Histology proven malignancy with imaging studies with evidence of liver metastasis and ascites
Malignant Budd Chiari Syndrome with associated ascites
Hepatocellular carcinoma and ascites
Chylous ascites due to lymphoma
Peritoneal carcinomatosis and concurrent ascites
Proven abdominal malignancy with concurrent ascites

Refractory / Recurrent ascites: One of the following criteria

Symptomatic ascites that recurred after one paracentesis in a patient with known malignant ascites.
Symptomatic ascites that did not respond clinically to at least two weeks of diuretics. Use of diuretics at the discretion of the treating physician.
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).
Removal of at least 5 L in the preceding two months for symptoms relief

Exclusion criteria:

Life expectancy less than one month
Coagulopathy (international normalized ratio [INR] > 2 that does not correct with fresh frozen plasma)
Hepatorenal syndrome
Active skin infections at abdomen before procedures
Inability to provide inform consent
Platelet counts < 50,000/mcL
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
Absolute neutrophil count <1000 / cu mm
Pregnant women
Multiloculated ascites

Sites / Locations

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

paracentesis

Pleurx catheter

Arm Description

cutting and draining procedure for malignant ascites

a catheter drainage system the subject uses himself/herself.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01077063

First Posted

February 25, 2010

Last Updated

October 6, 2015

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

1. Study Identification

Unique Protocol Identification Number

NCT01077063

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Terminated

Why Stopped

Study was closed by PI because of low enrollment.

Study Start Date

February 2010 (undefined)

Primary Completion Date

August 2013 (Actual)

Study Completion Date

August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malignant Ascites

Keywords

Pleurx catheter, malignant ascites

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

7 (Actual)

8. Arms, Groups, and Interventions

Arm Title

paracentesis

Arm Type

Active Comparator

Arm Description

cutting and draining procedure for malignant ascites

Arm Title

Pleurx catheter

Arm Type

Active Comparator

Arm Description

a catheter drainage system the subject uses himself/herself.

Intervention Type

Procedure

Intervention Name(s)

paracentesis

Intervention Description

surgical drainage of malignant ascites

Intervention Type

Device

Intervention Name(s)

Pleurx catheter

Intervention Description

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

Primary Outcome Measure Information:

Title

Safety of Pleurx Catheter or Paracentesis

Description

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: (Patients can receive chemotherapy at the discretion of treating oncologist) Patients with recurrent malignant ascites Patients with refractory malignant ascites Proven malignancy Age >= 18 years old Eastern Cooperative Oncology Group (ECOG) performance scale =< 2 Ability to understand and willingness to sign a written informed consent Definitions: Malignant ascites: One of the following criteria Positive ascitic fluid cytology Histology proven malignancy with imaging studies with evidence of liver metastasis and ascites Malignant Budd Chiari Syndrome with associated ascites Hepatocellular carcinoma and ascites Chylous ascites due to lymphoma Peritoneal carcinomatosis and concurrent ascites Proven abdominal malignancy with concurrent ascites Refractory / Recurrent ascites: One of the following criteria Symptomatic ascites that recurred after one paracentesis in a patient with known malignant ascites. Symptomatic ascites that did not respond clinically to at least two weeks of diuretics. Use of diuretics at the discretion of the treating physician. 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). Removal of at least 5 L in the preceding two months for symptoms relief Exclusion criteria: Life expectancy less than one month Coagulopathy (international normalized ratio [INR] > 2 that does not correct with fresh frozen plasma) Hepatorenal syndrome Active skin infections at abdomen before procedures Inability to provide inform consent Platelet counts < 50,000/mcL 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 Absolute neutrophil count <1000 / cu mm Pregnant women Multiloculated ascites

Facility Information:

Facility Name

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21205-2009

Country

United States

12. IPD Sharing Statement

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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

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