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