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Cervical Video Assisted Thoracoscopic Surgery (C-VATS) (CT0030)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor:
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier:
NCT01440244
First received: September 16, 2011
Last updated: September 25, 2014
Last verified: September 2014
  Purpose

Although thoracic NOTES may not be ready for human trials, a new minimally invasive technique to access the pleural cavity and perform pleural, pulmonary and mediastinal procedures would be possible. Cervical Video Assisted Thoracoscopic Surgery (C-VATS) is a technique that borrows from traditional VATS procedures, from cervical mediastinoscopy, and from flexible endoscopy. All of these procedures are very familiar to the thoracic surgeon.

The current feasibility and safety study examines C-VATS as a method of evaluating, biopsying and performing pleurodesis in patients with pleural disease and or effusion.


Condition Intervention
Lung Cancer
Procedure: Cervical mediastinoscopy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cervical Video Assisted Thoracoscopic Surgery (C-VATS)Using a Flexible Endoscope for Thoracoscopy

Further study details as provided by Centre hospitalier de l'Université de Montréal (CHUM):

Primary Outcome Measures:
  • procedure-related morbidity [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Intra-operative mortality In-hospital mortality 30-day mortality


Secondary Outcome Measures:
  • pain related to technique [ Time Frame: 3-6months ] [ Designated as safety issue: No ]
  • Procedural, hospitalization and overall cost [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: September 2011
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Single group assignment
Cervical mediastinoscopy
Procedure: Cervical mediastinoscopy
minimally invasive technique to perform pleural evaluation, pleural biopsy and pleurodesis

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01440244

Locations
Canada, Quebec
Centre Hospitalier de l'Université de Montréal Recruiting
Montréal, Quebec, Canada, H2L 4M1
Contact: Vicky Thiffault, RN, CCRP    514-890-8000 ext 23432    vicky.thiffault.chum@ssss.gouv.qc.ca   
Principal Investigator: Moishe Liberman, MD, PhD         
Sub-Investigator: Pasquale Ferraro, MD         
Sub-Investigator: André Duranceau, MD         
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Investigators
Principal Investigator: Moishe Liberman, MD, PhD Centre de Recherche du Centre Hospitalier de l'Université de Montréal
  More Information

No publications provided

Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT01440244     History of Changes
Other Study ID Numbers: CE 11.092
Study First Received: September 16, 2011
Last Updated: September 25, 2014
Health Authority: Canada: Ethics Review Committee
Canada: Health Canada

Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM):
mediastinoscopy
pleural evaluation
pleural biopsy
pleurodesis

ClinicalTrials.gov processed this record on November 25, 2014