NCT00761618

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
257

participants targeted

Target at P75+ for phase_2

Timeline
3mo left

Started Aug 2008

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress98%
Aug 2008Aug 2026

Study Start

First participant enrolled

August 22, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 25, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 29, 2008

Completed
17.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Last Updated

April 16, 2026

Status Verified

April 1, 2026

Enrollment Period

18 years

First QC Date

September 25, 2008

Last Update Submit

April 13, 2026

Conditions

Advanced CancerPleural Effusion

Keywords

Intrapleural catheterIPCPleurodesisPDPleural effusionFluid in the chest cavityRecurrent malignant pleural effusionMPEPleural inflammatory response

Outcome Measures

Primary Outcomes (1)

  • Time to Pleurodesis (TTP)

    Time to pleurodesis (TTP), defined as the time from catheter insertion to catheter removal.

    2 weeks after intrapleural catheter placement

Study Arms (2)

Arm 1 - Daily

EXPERIMENTAL

Intrapleural Catheters (IPC) drained every day

Procedure: Intrapleural catheter (IPC) drainedProcedure: IPC PlacementRadiation: Chest X-Ray

Arm 2 - 3 Times a Week

EXPERIMENTAL

IPC drained 3 times a week

Procedure: Intrapleural catheter (IPC) drainedProcedure: IPC PlacementRadiation: Chest X-Ray

Interventions

Intrapleural catheter (IPC) drainedPROCEDURE

IPC drained daily (Group 1) or 3 times per week (Group 2)

Arm 1 - DailyArm 2 - 3 Times a Week
IPC PlacementPROCEDURE

IPC placed in chest cavity to drain excess fluid

Also known as: Indwelling Pleural Catheter
Arm 1 - DailyArm 2 - 3 Times a Week
Chest X-RayRADIATION

Chest X-Rays at 3 and 6 month follow up visits

Arm 1 - DailyArm 2 - 3 Times a Week

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Pleural EffusionPleural Effusion, Malignant

Interventions

X-Rays

Condition Hierarchy (Ancestors)

Pleural DiseasesRespiratory Tract DiseasesPleural NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

Electromagnetic RadiationElectromagnetic PhenomenaMagnetic PhenomenaPhysical PhenomenaRadiationRadiation, Ionizing

Study Officials

  • Carlos A. Jimenez, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2008

First Posted

September 29, 2008

Study Start

August 22, 2008

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2026

Last Updated

April 16, 2026

Record last verified: 2026-04

Locations

US(1)