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History of Changes for Study: NCT00761618
Intrapleural Catheter Daily Versus Three Times a Week Drainage
Latest version (submitted August 24, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 September 26, 2008 None (earliest Version on record)
2 March 20, 2009 Recruitment Status, Study Status, Contacts/Locations, Eligibility and Conditions
3 February 17, 2010 Study Status
4 August 16, 2010 Study Status
5 November 30, 2010 Outcome Measures, Arms and Interventions and Study Status
6 May 3, 2011 Recruitment Status, Study Status, Contacts/Locations, Study Description and Study Design
7 September 28, 2011 Sponsor/Collaborators and Study Status
8 October 27, 2011 Study Status and Study Description
9 March 2, 2012 Study Status and Study Description
10 March 26, 2012 Study Description and Study Status
11 April 26, 2012 Study Status and Eligibility
12 July 12, 2012 Study Status
13 January 23, 2013 Study Status
14 July 24, 2013 Study Status
15 November 6, 2013 Outcome Measures, Study Description and Study Status
16 December 13, 2013 Study Status, Eligibility and Sponsor/Collaborators
17 December 19, 2013 Study Description, References, Arms and Interventions and Study Status
18 June 19, 2014 Study Status and Study Identification
19 July 17, 2014 Study Description and Study Status
20 September 18, 2014 Contacts/Locations, Arms and Interventions, Study Status, Study Design and Study Description
21 December 23, 2014 Recruitment Status, Study Status and Contacts/Locations
22 December 29, 2015 Study Status
23 October 14, 2016 Study Status
24 November 23, 2016 Study Status and Study Description
25 January 8, 2018 Study Status and Oversight
26 January 11, 2019 Study Status
27 May 9, 2019 Study Status
28 July 10, 2020 Study Status
29 February 11, 2022 Study Status and Study Design
30 June 25, 2022 Study Status, Study Design, References and Study Identification
31 August 24, 2022 Study Status
Comparison Format:

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Study NCT00761618
Submitted Date:  September 26, 2008 (v1)

Open or close this module Study Identification
Unique Protocol ID: 2007-0808
Brief Title: Intrapleural Catheter Daily Versus Three Times a Week Drainage
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
Secondary IDs:
Open or close this module Study Status
Record Verification: September 2008
Overall Status: Recruiting
Study Start: August 2008
Primary Completion: August 2011 [Anticipated]
Study Completion:
First Submitted: September 25, 2008
First Submitted that
Met QC Criteria:
September 26, 2008
First Posted: September 29, 2008 [Estimate]
Last Update Submitted that
Met QC Criteria:
September 26, 2008
Last Update Posted: September 29, 2008 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: M.D. Anderson Cancer Center
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
Brief Summary: The investigators 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) will not result in fewer patients with pleurodesis (Pd).
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 M. D. Anderson, patients are told to drain their IPC every day. At other institutions, patients are told to drain their IPC less often.

Before IPC Placement:

Before you can have the IPC inserted, the following tests and procedures will be performed to help the doctor decide if you need to have an IPC inserted:

  • You will perform a 6 minute walk test to learn your check your breathing ability and fatigue level. To perform the walk test, you will be asked to walk as far as possible around cones on a flat indoor course that is about 40 yards long. You will walk at your own pace and can take breaks at any time if necessary.
  • After signing this consent, you will fill out 2 questionnaires asking questions about how you feel and any symptoms you may have. Both questionnaires will take about 20-30 minutes to complete.

IPC placement:

You will have an IPC placed to drain the fluid in your chest cavity. You will be given a separate consent for to sign for this procedure and your doctor will give you detailed instructions regarding the procedure itself.

Study Groups:

A chest x-ray will be performed right after the IPC placement. You will be randomly assigned (as in the flip of a coin) to 1 of 2 groups, after your chest x-ray or the following day when you return to clinic for follow up. Group 1 will have their IPC drained every day, and Group 2 will have their IPC drained 3 times a week (Monday, Wednesday, and Friday or Tuesday, Thursday, and Saturday). You will be given detailed instructions on when and how to drain your catheter.

Follow-Up Visits:

Two (2) weeks after you receive the IPC, you will return to the clinic for a follow-up visit so the doctor can check your IPC for possible leaking, infection, and see how much pleural fluid has drained. After the follow-up visit at 2 weeks, you will come into the clinic every 4 weeks until your IPC is removed. During each follow-up visit the following tests and procedures will be performed to see how your condition has changed:

  • You will have a chest x-ray to see if the amount of pleural fluid has decreased and to see if your lung has re-expanded.
  • You will perform the 6 minute walk test.
  • You will complete the same 2 questionnaires.
  • The IPC will be drained.

After the IPC is removed, at 3 and 6 months, you will have follow-up visits at M. D. Anderson or at your local doctor's office. At these visits you will have chest x-rays to see if the pleural fluid has come back or not.

The study personnel will contact you by phone, email or mail periodically during the study and at 3 months and 6 months after the IPC has been removed to check on your status. The phone calls, email, or mail follow-up will take about 5-10 minutes to complete. You will be asked how you are doing and if you have any questions or concerns that you may want to discuss with the your doctor. You will also be asked if you have had a chest x-ray since being off study. If you have had an x-ray, you will be asked to share the results with the study doctor.

This is an investigational study. Up to 310 patients will take part in this study. All will be enrolled at M. D. Anderson.

Open or close this module Conditions
Conditions: Advanced Cancer
Pleural Effusion
Keywords: intrapleural catheter
IPC
pleurodesis
Pd
pleural effusion
Recurrent malignant pleural effusion
MPE
pleural inflammatory response
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Single Group Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 310 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: 1
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 Names:
  • Indwelling Pleural Catheter
Radiation: Chest X-Ray
Chest X-Rays at 3 and 6 month follow up visits
Experimental: 2
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 Names:
  • Indwelling Pleural Catheter
Radiation: Chest X-Ray
Chest X-Rays at 3 and 6 month follow up visits
Open or close this module Outcome Measures
Primary Outcome Measures:
1. To learn if draining the IPC every day is better than draining it 3 times a week
[ Time Frame: 3 Years ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion:

  1. Patients with symptomatic pleural effusion requiring placement of an IPC.
  2. Signed informed consent prior to any study related procedures.
  3. Subject must be age 18 years or over.

Exclusion:

  1. 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.
  2. Evidence of empyema or history of empyema of the affected hemithorax
  3. Non-correctable bleeding diathesis
  4. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
  5. 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.
  6. Participation in any clinical trial that prevents randomization of the subject to either strategy.
  7. Clinical evidence of skin infection at the potential site of IPC placement.
Open or close this module Contacts/Locations
Central Contact Person: Carlos A. Jimenez, MD
Telephone: 713-563-4252
Central Contact Backup: Dana Bethancourt, CCRC, RN
Study Officials: Carlos A. Jimenez, MD
Principal Investigator
UT MD Anderson Cancer Center
Locations: United States, Texas
UT MD Anderson Cancer Center
[Recruiting]
Houston, Texas, United States, 77030
Contact:Contact: Linda Foot 713-563-8841
Contact:Principal Investigator: Carlos A. Jimenez, MD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links: Description: MD Anderson Cancer Center website
Available IPD/Information:

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