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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. Identifier: NCT01409551
Recruitment Status : Completed
First Posted : August 4, 2011
Last Update Posted : November 17, 2014
Information provided by (Responsible Party):
Nikolaos Barbetakis, Theagenio Cancer Hospital

Brief Summary:
Aim of this study is to compare two methods of pleurodesis for refractory malignant pleural effusions, in terms of safety and efficacy.

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever

Arm Intervention/treatment
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.

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 75 Years   (Child, Adult, Older Adult)
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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01409551

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

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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
First Posted: August 4, 2011    Key Record Dates
Last Update Posted: November 17, 2014
Last Verified: November 2014
Keywords provided by Nikolaos Barbetakis, Theagenio Cancer Hospital:
Pleural effusion
Additional relevant MeSH terms:
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Pleural Effusion, Malignant
Pleural Effusion
Pleural Diseases
Respiratory Tract Diseases
Pleural Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site