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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Theagenio Cancer Hospital
Sponsor:
Information provided by (Responsible Party):
Nikolaos Barbetakis, Theagenio Cancer Hospital
ClinicalTrials.gov Identifier:
NCT01409551
First received: August 3, 2011
Last updated: March 26, 2014
Last verified: March 2014
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Morbidity [ Time Frame: Postoperative period (7 days following intervention) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: August 2011
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (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.

  Eligibility

Ages Eligible for Study:   up to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01409551

Contacts
Contact: Nikolaos Barbetakis, MD,PhD +302310898304 nibarbet@yahoo.gr

Locations
Greece
Thoracic Surgery Department, Theagenio Cancer Hospital Recruiting
Thessaloniki, Greece, 54007
Contact: Athanassios Kleontas, MD       kleontas@gmail.com   
Sub-Investigator: Athanassios Kleontas, MD         
Sponsors and Collaborators
Theagenio Cancer Hospital
Investigators
Principal Investigator: Nikolaos Barbetakis, MD, PhD Theagenio Cancer Hospital
  More Information

No publications provided

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
Study First Received: August 3, 2011
Last Updated: March 26, 2014
Health Authority: Theagenio Cancer Hospital, Ethics Committee,Greece':'

Keywords provided by Theagenio Cancer Hospital:
Pleural effusion
VATS
hyperthermia
thoracostomy
pleurodesis

Additional relevant MeSH terms:
Fever
Pleural Effusion
Pleural Effusion, Malignant
Body Temperature Changes
Signs and Symptoms
Pleural Diseases
Respiratory Tract Diseases
Pleural Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms

ClinicalTrials.gov processed this record on August 19, 2014