Cervical Video Assisted Thoracoscopic Surgery (C-VATS)

Lung Cancer Clinical Trial

— CT0030  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01440244
• Other study ID #: CE 11.092
• Status: Recruiting
• Phase: N/A
• Start date: September 2011
• Est. completion date: December 2024

Study information

• Verified date: January 2023
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer

Intervention

Procedure:
• Cervical mediastinoscopy
minimally invasive technique to perform pleural evaluation, pleural biopsy and pleurodesis

Locations

Country	Name	City	State
Canada	Centre Hospitalier de l'Université de Montréal	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	procedure-related morbidity	Intra-operative mortality In-hospital mortality 30-day mortality	30 days
Secondary	pain related to technique		3-6months
Secondary	Procedural, hospitalization and overall cost		3 months