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

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ClinicalTrials.gov Identifier: NCT01409551
Recruitment Status : Completed
First Posted : August 4, 2011
Last Update Posted : November 17, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
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
Safety of Intervention Efficacy of Intervention Cost Effectiveness Procedure: VATS hyperthermic chemoperfusion Procedure: 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.

Study Design

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
Primary Completion Date : November 2014
Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever
U.S. FDA Resources

Arms and Interventions

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.


Outcome Measures

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) ]

Eligibility Criteria

Information from the National Library of Medicine

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

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

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 ClinicalTrials.gov identifier (NCT number): NCT01409551


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

Responsible Party: Nikolaos Barbetakis, Head of Thoracic Surgery Department, Theagenio Cancer Hospital
ClinicalTrials.gov 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
VATS
hyperthermia
thoracostomy
pleurodesis

Additional relevant MeSH terms:
Pleural Effusion
Fever
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