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

This study has been completed.
Information provided by (Responsible Party):
Nikolaos Barbetakis, Theagenio Cancer Hospital Identifier:
First received: August 3, 2011
Last updated: November 14, 2014
Last verified: November 2014
Aim of this study is to compare two methods of pleurodesis for refractory malignant pleural effusions, in terms of safety and efficacy.

Condition Intervention
Safety of Intervention
Efficacy of Intervention
Cost Effectiveness
Procedure: VATS hyperthermic chemoperfusion
Procedure: Bedside talc slurry pleurodesis

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Video-assisted Hyperthermic Pleural Chemoperfusion Versus Bed-side Talc Slurry Pleurodesis for Refractory Malignant Pleural Effusions.

Resource links provided by NLM:

Further study details as provided by Theagenio Cancer Hospital:

Primary Outcome Measures:
  • Recurrence of pleural effusion [ Time Frame: 2 months following intervention ]

Secondary Outcome Measures:
  • Morbidity [ Time Frame: Postoperative period (7 days following intervention) ]

Enrollment: 60
Study Start Date: August 2011
Study Completion Date: November 2014
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

Ages Eligible for Study:   up to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01409551

Thoracic Surgery Department, Theagenio Cancer Hospital
Thessaloniki, Greece, 54007
Sponsors and Collaborators
Theagenio Cancer Hospital
Principal Investigator: Nikolaos Barbetakis, MD, PhD Theagenio Cancer Hospital
  More Information

Responsible Party: Nikolaos Barbetakis, Head of Thoracic Surgery Department, Theagenio Cancer Hospital Identifier: NCT01409551     History of Changes
Other Study ID Numbers: Theagenio Thoracic Surgery 2
Study First Received: August 3, 2011
Last Updated: November 14, 2014

Keywords provided by Theagenio Cancer Hospital:
Pleural effusion

Additional relevant MeSH terms:
Pleural Effusion
Pleural Effusion, Malignant
Pleural Diseases
Respiratory Tract Diseases
Body Temperature Changes
Signs and Symptoms
Pleural Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms processed this record on May 22, 2017