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Video-assisted Hyperthermic Pleural Chemoperfusion vs Talc Pleurodesis for Refractory Malignant Pleural Effusions.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01409551
First Posted: August 4, 2011
Last Update Posted: November 17, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Nikolaos Barbetakis, Theagenio Cancer Hospital
August 3, 2011
August 4, 2011
November 17, 2014
August 2011
November 2014   (Final data collection date for primary outcome measure)
Recurrence of pleural effusion [ Time Frame: 2 months following intervention ]
Same as current
Complete list of historical versions of study NCT01409551 on ClinicalTrials.gov Archive Site
Morbidity [ Time Frame: Postoperative period (7 days following intervention) ]
Same as current
Not Provided
Not Provided
 
Video-assisted Hyperthermic Pleural Chemoperfusion vs Talc Pleurodesis for Refractory Malignant Pleural Effusions.
Video-assisted Hyperthermic Pleural Chemoperfusion Versus Bed-side Talc Slurry Pleurodesis for Refractory Malignant Pleural Effusions.
Aim of this study is to compare two methods of pleurodesis for refractory malignant pleural effusions, in terms of safety and efficacy.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Safety of Intervention
  • Efficacy of Intervention
  • Cost Effectiveness
  • Procedure: VATS hyperthermic chemoperfusion
    VATS, adhesiolysis, hyperthermic chemoperfusion (with a pump machine)
  • Procedure: Bedside talc slurry pleurodesis
    Bedside tube thoracostomy under local anesthesia. Bedside talc slurry pleurodesis.
  • Active Comparator: VATS hyperthermic pleural chemoperfusion
    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.
    Intervention: Procedure: VATS hyperthermic chemoperfusion
  • Active Comparator: Bedside talc slurry pleurodesis
    The patients undergo tube thoracostomy under local anesthesia. When the lung is fully expanded, talc slurry bed-side pleurodesis is performed.
    Intervention: Procedure: Bedside talc slurry pleurodesis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
November 2014
November 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
up to 75 Years   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Greece
 
 
NCT01409551
Theagenio Thoracic Surgery 2
No
Not Provided
Not Provided
Nikolaos Barbetakis, Theagenio Cancer Hospital
Theagenio Cancer Hospital
Not Provided
Principal Investigator: Nikolaos Barbetakis, MD, PhD Theagenio Cancer Hospital
Theagenio Cancer Hospital
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP