Video-assisted Hyperthermic Pleural Chemoperfusion vs Talc Pleurodesis for Refractory Malignant Pleural Effusions.
|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.|
|ClinicalTrials.gov Identifier: NCT01409551|
Recruitment Status : Completed
First Posted : August 4, 2011
Last Update Posted : November 17, 2014
|Condition or disease||Intervention/treatment||Phase|
|Safety of Intervention Efficacy of Intervention Cost Effectiveness||Procedure: VATS hyperthermic chemoperfusion Procedure: Bedside talc slurry pleurodesis||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Video-assisted Hyperthermic Pleural Chemoperfusion Versus Bed-side Talc Slurry Pleurodesis for Refractory Malignant Pleural Effusions.|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||November 2014|
|Actual Study Completion Date :||November 2014|
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.
Procedure: VATS hyperthermic chemoperfusion
VATS, adhesiolysis, hyperthermic chemoperfusion (with a pump machine)
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.
Procedure: Bedside talc slurry pleurodesis
Bedside tube thoracostomy under local anesthesia. Bedside talc slurry pleurodesis.
- Recurrence of pleural effusion [ Time Frame: 2 months following intervention ]
- Morbidity [ Time Frame: Postoperative period (7 days following intervention) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01409551
|Thoracic Surgery Department, Theagenio Cancer Hospital|
|Thessaloniki, Greece, 54007|
|Principal Investigator:||Nikolaos Barbetakis, MD, PhD||Theagenio Cancer Hospital|