Cervical Video Assisted Thoracoscopic Surgery (C-VATS)

NCT01440244 | Terminated

• 1 other identifier: CE 11.092
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Cancer

Keywords

mediastinoscopy; pleural evaluation; pleural biopsy; pleurodesis

Outcome Measures

Primary Outcomes (1)

• procedure-related morbidity

  Intra-operative mortality In-hospital mortality 30-day mortality

  30 days

Secondary Outcomes (2)

• pain related to technique

  3-6months

• Procedural, hospitalization and overall cost

  3 months

Study Arms (1)

Single group assignment

OTHER

Cervical mediastinoscopy

Procedure: Cervical mediastinoscopy

Interventions

Cervical mediastinoscopy PROCEDURE

minimally invasive technique to perform pleural evaluation, pleural biopsy and pleurodesis

Single group assignment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible patients will be those that would be candidates for the same pleural procedure (biopsy, drainage and pleurodesis) using a VATS technique

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (1)

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2L 4M1, Canada

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Moishe Liberman, MD, PhD

  Centre de Recherche du Centre Hospitalier de l'Université de Montréal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2011
• First Posted: September 26, 2011
• Study Start: September 1, 2011
• Primary Completion: July 12, 2024
• Study Completion: July 12, 2024
• Last Updated: July 16, 2024

Record last verified: 2024-07

Locations

CA (1)