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

This study is currently recruiting participants.
Verified March 2014 by Theagenio Cancer Hospital
Sponsor:
Information provided by (Responsible Party):
Nikolaos Barbetakis, Theagenio Cancer Hospital
ClinicalTrials.gov Identifier:
NCT01409551
First received: August 3, 2011
Last updated: March 26, 2014
Last verified: March 2014

August 3, 2011
March 26, 2014
August 2011
March 2016   (final data collection date for primary outcome measure)
Recurrence of pleural effusion [ Time Frame: 2 months following intervention ] [ Designated as safety issue: Yes ]
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) ] [ Designated as safety issue: Yes ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.
 
Recruiting
60
March 2016
March 2016   (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
Both
up to 75 Years
No
Contact: Nikolaos Barbetakis, MD,PhD +302310898304 nibarbet@yahoo.gr
Greece
 
NCT01409551
Theagenio Thoracic Surgery 2
No
Nikolaos Barbetakis, Theagenio Cancer Hospital
Theagenio Cancer Hospital
Not Provided
Principal Investigator: Nikolaos Barbetakis, MD, PhD Theagenio Cancer Hospital
Theagenio Cancer Hospital
March 2014

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