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

July 15, 2024 updated by: Centre hospitalier de l'Université de Montréal (CHUM)

Cervical Video Assisted Thoracoscopic Surgery (C-VATS)Using a Flexible Endoscope for Thoracoscopy

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

4

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

  • Canada
    • Quebec
      • Montréal, Quebec, Canada, H2L 4M1
        • Centre Hospitalier de l'Universite de Montreal

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Single group assignment
Cervical mediastinoscopy
Procedure: Cervical mediastinoscopy
minimally invasive technique to perform pleural evaluation, pleural biopsy and pleurodesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
procedure-related morbidity
Time Frame: 30 days
Intra-operative mortality In-hospital mortality 30-day mortality
30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
pain related to technique
Time Frame: 3-6months
3-6months
Procedural, hospitalization and overall cost
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Investigators

  • Principal Investigator: Moishe Liberman, MD, PhD, Centre de recherche du Centre Hospitalier de l'Universite de Montreal

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

September 1, 2011

Primary Completion (Actual)

July 12, 2024

Study Completion (Actual)

July 12, 2024

Study Registration Dates

First Submitted

September 16, 2011

First Submitted That Met QC Criteria

September 23, 2011

First Posted (Estimated)

September 26, 2011

Study Record Updates

Last Update Posted (Actual)

July 16, 2024

Last Update Submitted That Met QC Criteria

July 15, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CE 11.092

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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