- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01409551
Video-assisted Hyperthermic Pleural Chemoperfusion vs Talc Pleurodesis for Refractory Malignant Pleural Effusions.
November 14, 2014 updated by: Nikolaos Barbetakis, Theagenio Cancer Hospital
Video-assisted Hyperthermic Pleural Chemoperfusion Versus Bed-side Talc Slurry Pleurodesis for Refractory Malignant Pleural Effusions.
Aim of this study is to compare two methods of pleurodesis for refractory malignant pleural effusions, in terms of safety and efficacy.
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Thessaloniki, Greece, 54007
- Thoracic Surgery Department, Theagenio Cancer Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 75 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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.
|
Bedside tube thoracostomy under local anesthesia.
Bedside talc slurry pleurodesis.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Recurrence of pleural effusion
Time Frame: 2 months following intervention
|
2 months following intervention
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Morbidity
Time Frame: Postoperative period (7 days following intervention)
|
Postoperative period (7 days following intervention)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Nikolaos Barbetakis, MD, PhD, Theagenio Cancer Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2011
Primary Completion (Actual)
November 1, 2014
Study Completion (Actual)
November 1, 2014
Study Registration Dates
First Submitted
August 3, 2011
First Submitted That Met QC Criteria
August 3, 2011
First Posted (Estimate)
August 4, 2011
Study Record Updates
Last Update Posted (Estimate)
November 17, 2014
Last Update Submitted That Met QC Criteria
November 14, 2014
Last Verified
November 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Theagenio Thoracic Surgery 2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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