Back to resultsVideo-assisted Hyperthermic Pleural Chemoperfusion vs Talc Pleurodesis for Refractory Malignant Pleural Effusions.
Primary Purpose
Safety of Intervention, Efficacy of Intervention, Cost Effectiveness
Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
VATS hyperthermic chemoperfusion
Bedside talc slurry pleurodesis
Sponsored by
About this trial
This is an interventional treatment trial for Safety of Intervention focused on measuring Pleural effusion, VATS, hyperthermia, thoracostomy, pleurodesis
Eligibility Criteria
Inclusion Criteria:
- Recurrent symptomatic malignant pleural effusion
- No prior intrapleural therapy
- Abscence of bronchial obstruction or fibrosis preventing lung reexpansion
- No systemic chemotherapy immediately prior to or during the first 30-day interval following pleurodesis
Exclusion Criteria:
- Poor Karnofsky Performance Status
Sites / Locations
- Thoracic Surgery Department, Theagenio Cancer Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
VATS hyperthermic pleural chemoperfusion
Bedside talc slurry pleurodesis
Arm Description
The patients undergo a VATS drainage of pleural effusion with adhesiolysis and complete mobilization of the lung, following by a 1 hour hyperthermic (40oC)chemoperfusion by means of a pump machine.
The patients undergo tube thoracostomy under local anesthesia. When the lung is fully expanded, talc slurry bed-side pleurodesis is performed.
Outcomes
Primary Outcome Measures
Recurrence of pleural effusion
Secondary Outcome Measures
Morbidity
Full Information
NCT ID
NCT01409551
First Posted
August 3, 2011
Last Updated
November 14, 2014
Sponsor
Theagenio Cancer Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01409551
Brief Title
Video-assisted Hyperthermic Pleural Chemoperfusion vs Talc Pleurodesis for Refractory Malignant Pleural Effusions.
Official Title
Video-assisted Hyperthermic Pleural Chemoperfusion Versus Bed-side Talc Slurry Pleurodesis for Refractory Malignant Pleural Effusions.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Theagenio Cancer Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Aim of this study is to compare two methods of pleurodesis for refractory malignant pleural effusions, in terms of safety and efficacy.
Detailed Description
The study compares prospectively two groups of patients with refractory maignant pleural effusion. Group A consists of patients undergoing video-assisted hyperthermic pleural chemoperfusion (with a pump machine) and group B includes patients undergoing bed-side tube thoracostomy and talc slurry pleurodesis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Safety of Intervention, Efficacy of Intervention, Cost Effectiveness
Keywords
Pleural effusion, VATS, hyperthermia, thoracostomy, pleurodesis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VATS hyperthermic pleural chemoperfusion
Arm Type
Active Comparator
Arm Description
The patients undergo a VATS drainage of pleural effusion with adhesiolysis and complete mobilization of the lung, following by a 1 hour hyperthermic (40oC)chemoperfusion by means of a pump machine.
Arm Title
Bedside talc slurry pleurodesis
Arm Type
Active Comparator
Arm Description
The patients undergo tube thoracostomy under local anesthesia. When the lung is fully expanded, talc slurry bed-side pleurodesis is performed.
Intervention Type
Procedure
Intervention Name(s)
VATS hyperthermic chemoperfusion
Intervention Description
VATS, adhesiolysis, hyperthermic chemoperfusion (with a pump machine)
Intervention Type
Procedure
Intervention Name(s)
Bedside talc slurry pleurodesis
Intervention Description
Bedside tube thoracostomy under local anesthesia. Bedside talc slurry pleurodesis.
Primary Outcome Measure Information:
Title
Recurrence of pleural effusion
Time Frame
2 months following intervention
Secondary Outcome Measure Information:
Title
Morbidity
Time Frame
Postoperative period (7 days following intervention)
10. Eligibility
Sex
All
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Recurrent symptomatic malignant pleural effusion
No prior intrapleural therapy
Abscence of bronchial obstruction or fibrosis preventing lung reexpansion
No systemic chemotherapy immediately prior to or during the first 30-day interval following pleurodesis
Exclusion Criteria:
Poor Karnofsky Performance Status
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nikolaos Barbetakis, MD, PhD
Organizational Affiliation
Theagenio Cancer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thoracic Surgery Department, Theagenio Cancer Hospital
City
Thessaloniki
ZIP/Postal Code
54007
Country
Greece
12. IPD Sharing Statement
Learn more about this trial
Video-assisted Hyperthermic Pleural Chemoperfusion vs Talc Pleurodesis for Refractory Malignant Pleural Effusions.
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