Cervical Video Assisted Thoracoscopic Surgery (C-VATS)Using a Flexible Endoscope for Thoracoscopy
18 Years
N/A
Both
Lung Cancer
Trial Information
Cervical Video Assisted Thoracoscopic Surgery (C-VATS)Using a Flexible Endoscope for Thoracoscopy
Hypothesis: C-VATS is a feasible and safe method of entering the pleural space in order to
perform pleural evaluation, pleural biopsy and pleurodesis in patients with pleural disease
and/or pleural effusions.
Objectives: Evaluate the safety and feasibility of C-VATS in patients with pleural disease.
Design: Prospective, cohort, feasibility and safety study.
Methods: Patients referred to all thoracic surgeons in the Division of Thoracic Surgery at
the CHUM Notre Dame campus for the diagnosis or treatment of pleural based diseases will be
screened for enrolment. The investigators plan to recruit 10 patients in this initial study.
Eligible patients will be consented by one of the thoracic surgeons at the CHUM.
All procedures will be performing in the operating room at the CHUM Notre Dame Hospital. All
patients will be admitted prior to their procedure and treated on the post-operative
thoracic surgery ward using standard post-VATS procedural treatments. All cause, as well as
procedure specific morbidity will be recorded by the study investigators on the day of the
procedure, every day in hospital until discharge and at 1 week, 4 weeks and 12 weeks post
procedure.
Inclusion Criteria:
- Eligible patients will be those that would be candidates for the same pleural
procedure (biopsy, drainage and pleurodesis) using a VATS technique
Exclusion Criteria:
- Anticoagulation including Warfarin, Heparin or Clopidogrel which cannot be stopped
- Patients less than 18 years old
- Pregnant patients
- Patient unable to extend neck fully
- Patients with cervical spine instability
- Patients having had previous neck or mediastinal surgery which would preclude
mediastinoscopy
- Patients having previously undergone mediastinal irradiation
- Patients having been previously diagnosed with mediastinitis
- Active cervical cutaneous or deep cervical infections
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
procedure-related morbidity
Outcome Description:
Intra-operative mortality In-hospital mortality 30-day mortality
Outcome Time Frame:
30 days
Safety Issue:
Yes
Principal Investigator
Moishe Liberman, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
Authority:
Canada: Ethics Review Committee
Study ID:
CE 11.092
NCT ID:
NCT01440244
Start Date:
September 2011
Completion Date:
February 2014
Related Keywords:
- Lung Cancer
- mediastinoscopy
- pleural evaluation
- pleural biopsy
- pleurodesis
- Lung Neoplasms
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