Status:
ACTIVE_NOT_RECRUITING
Intrapleural Catheter Daily Versus Three Times a Week Drainage
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
C. R. Bard
Conditions:
Advanced Cancer
Pleural Effusion
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The goal of this clinical research study is to learn if draining the IPC every day is better at than draining it 3 times a week.
Detailed Description
An IPC is a silicone (rubberlike) tube that is inserted into the chest cavity to drain excess fluid that is in your chest. At MD Anderson, patients are told to drain their IPC every day. At other inst...
Eligibility Criteria
Inclusion
- Patients with symptomatic pleural effusion requiring placement of an IPC.
- Signed informed consent prior to any study related procedures.
- Subject must be age 18 years or over.
Exclusion
- Any of the following interventions on the affected hemithorax: prior IPC, prior chest tube placement, history of chemical or mechanical pleurodesis, history of thoracotomy within 4 weeks incompletely healed surgical incision before randomization.
- Evidence of empyema or history of empyema of the affected hemithorax
- Non-correctable bleeding diathesis
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
- Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the Principal Investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the protocol.
- Participation in any clinical trial that prevents randomization of the subject to either strategy.
- Clinical evidence of skin infection at the potential site of IPC placement.
- Current or prior IPC placement, or any intervention to manage recurrent malignant pleural effusion on the contralateral hemithorax (excluding thoracentesis).
Key Trial Info
Start Date :
August 22 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2026
Estimated Enrollment :
257 Patients enrolled
Trial Details
Trial ID
NCT00761618
Start Date
August 22 2008
End Date
August 31 2026
Last Update
October 28 2025
Active Locations (1)
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1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030