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Slow recruitment
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single group assignment | Other | Cervical mediastinoscopy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cervical mediastinoscopy | Procedure | minimally invasive technique to perform pleural evaluation, pleural biopsy and pleurodesis |
|
| Measure | Description | Time Frame |
|---|---|---|
| procedure-related morbidity | Intra-operative mortality In-hospital mortality 30-day mortality | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| pain related to technique | 3-6months | |
| Procedural, hospitalization and overall cost | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Moishe Liberman, MD, PhD | Centre de Recherche du Centre Hospitalier de l'Université de Montréal | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier de l'Université de Montréal | Montreal | Quebec | H2L 4M1 | Canada |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |