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CompletedNCT01409551Updated Nov 17, 2014

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

An interventional study of VATS hyperthermic chemoperfusion and Bedside talc slurry pleurodesis in Safety of Intervention, Efficacy of Intervention and Cost Effectiveness, sponsored by Theagenio Cancer Hospital. Completed at 1 site in Greece. Open to participants aged Up to 75 Years. Per ClinicalTrials.gov, last updated 2014-11-17.

Sponsored by Theagenio Cancer Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
Up to 75 Years
Sex
All
01

Study summary

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

Read the 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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Conditions studied

  • Safety of Intervention
  • Efficacy of Intervention
  • Cost Effectiveness

Keywords

  • Pleural effusion
  • VATS
  • hyperthermia
  • thoracostomy
  • pleurodesis
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In context

Pleural Effusion

335 studies on the registry are indexed under Pleural Effusion; 63 are open to participants now.

This study's enrollment of 60 is close to the median of 62 across 220 interventional studies indexed under Pleural Effusion.

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Lead sponsor

Theagenio Cancer Hospital is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Poor Karnofsky Performance Status
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • ProcedureVATS hyperthermic chemoperfusion

    VATS, adhesiolysis, hyperthermic chemoperfusion (with a pump machine)

  • ProcedureBedside talc slurry pleurodesis

    Bedside tube thoracostomy under local anesthesia. Bedside talc slurry pleurodesis.

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What researchers measure

Primary outcomes

  1. Recurrence of pleural effusion

    Time frame: 2 months following intervention

Secondary outcomes

  1. Morbidity

    Time frame: Postoperative period (7 days following intervention)

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Study locations

1 site
  • Thoracic Surgery Department, Theagenio Cancer Hospital
    Thessaloniki, 54007, Greece
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 17, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01409551
Lead sponsor
Theagenio Cancer Hospital
Responsible party
Nikolaos Barbetakis (Head of Thoracic Surgery Department, Theagenio Cancer Hospital) — Principal investigator
First posted
Aug 4, 2011
Start date
Aug 2011
Primary completion
Nov 2014
Completion
Nov 2014
Last update
Nov 17, 2014

Study contacts

Nikolaos Barbetakis, MD, PhD
principal investigator · Theagenio Cancer Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.

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