Intrapleural Catheter Daily Versus Three Times a Week Drainage
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Purpose
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.
Objectives:
Primary Objective:
Our primary objective is to show that draining the intrapleural catheter (IPC) every day (study arm ED) rather than 3 days a week (study arm TDW) results in an earlier removal of the catheter.
Secondary Objectives:
To compare on each drainage strategy:
1.1 Incidence of pleurodesis. 1.2 Survival after IPC insertion. 1.3 Incidence of secondary failures after IPC removal. 1.4 Incidence of partially successful pleurodesis. 1.5 Incidence of intrapleural catheter related infections. 1.6 Incidence of intrapleural catheter occlusions. 1.7 Incidence of other complications (bleeding, pneumothorax, persistent ipsilateral chest pain after IPC insertion).
1.8 Distance in meters on a six-minute walk test (6MWT) before IPC insertion, after approximately 2 weeks and at the time of removal.
1.9 Estimated adequate lung re-expansion visualized on radiological studies immediately after IPC insertion, after approximately 2 weeks and at the time of removal 1.10 ECOG performance status before IPC insertion, after approximately 2 weeks and at the time of removal (Appendix A).
1.11 Palliation of dyspnea using St. George's respiratory questionnaire. (Appendix B).
1.12 Quality of life using the EuroQOL (EQ-5D, Appendix D). 1.13 To compare on pleural fluid samples D-Dimer, TNF-alpha, TGF-beta1, VEGF, PAI-1 and IL-8, at the time of IPC placement, and within 12 to 72 hours, two weeks, and at the time of IPC removal.
1.14 Total number of pleural fluid drainages using the intrapleural catheter.
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced Cancer Pleural Effusion |
Procedure: Intrapleural catheter (IPC) drained Procedure: IPC Placement Radiation: Chest X-Ray |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Effectiveness of Daily Versus Three Times a Week Drainage After Placement of Intrapleural Catheters for the Palliative Management of Pleural Effusions Associated With Malignancies |
- Number of Patients with Pleurodesis (Pd) [ Time Frame: 3 Years ] [ Designated as safety issue: No ]Cochran-Mantel Haenszel (1952, 1959) chi-square test used to compare 2 study arms with respect to Pd rate in order to test if draining intrapleural catheter (IPC) every day is better than draining it 3 times a week.
| Estimated Enrollment: | 250 |
| Study Start Date: | March 2009 |
| Estimated Primary Completion Date: | August 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm 1 - Daily
IPC drained every day
|
Procedure: Intrapleural catheter (IPC) drained
IPC drained daily (Group 1) or 3 times per week (Group 2)
Procedure: IPC Placement
IPC placed in chest cavity to drain excess fluid
Other Name: Indwelling Pleural Catheter
Radiation: Chest X-Ray
Chest X-Rays at 3 and 6 month follow up visits
|
|
Experimental: Arm 2 - 3xWeek
IPC drained 3 times a week
|
Procedure: Intrapleural catheter (IPC) drained
IPC drained daily (Group 1) or 3 times per week (Group 2)
Procedure: IPC Placement
IPC placed in chest cavity to drain excess fluid
Other Name: Indwelling Pleural Catheter
Radiation: Chest X-Ray
Chest X-Rays at 3 and 6 month follow up visits
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 Criteria:
- 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 on the contralateral hemithorax.
Contacts and Locations| Contact: Carlos A. Jimenez, MD | 713-563-4252 | |
| Contact: Dana Bethancourt, CCRC, RN |
| United States, Texas | |
| UT MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Linda Foot 713-563-8841 | |
| Principal Investigator: Carlos A. Jimenez, MD | |
| Principal Investigator: | Carlos A. Jimenez, MD | UT MD Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00761618 History of Changes |
| Other Study ID Numbers: | 2007-0808 |
| Study First Received: | September 25, 2008 |
| Last Updated: | January 23, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
Intrapleural catheter IPC Pleurodesis PD Pleural effusion |
Fluid in the chest cavity Recurrent malignant pleural effusion MPE Pleural inflammatory response |
Additional relevant MeSH terms:
|
Pleural Effusion Neoplasms Pleural Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 19, 2013