Lung Cancer, Thoracic Neoplasm
Conditions
Keywords
Palpation, Tactile image sensor, Lung ultrasound, VATS procedures
Brief summary
Evaluation of the ability of the Palpator to detect hidden (occult) lung tumours that cannot be visualized or palpated using the traditional methods of visual inspection, grasper palpation, and VATS ultrasound.
Detailed description
All procedures will be performed with the patient under general anesthesia with single lung ventilation through double-lumen endotracheal intubation. Three to four thoracoports, no larger than 12 mm, will be inserted in the intercostal spaces as needed. After VATS port placement, the pleural cavity will be insufflated with CO2 to a maximum pressure of 8 mm Hg to assist with lung deflation. A standard VATS pleuroscopy will be performed to visually search for the nodule and its position confirmed with sequential assessment using a grasper, the Palpator, the VATS ultrasound probe, and then finger palpation. This will ensure that all patients will have the opportunity to avoid a large thoracotomy if the lesion can't be identified by the Palpator. If the lesion can be detected either visually or by grasper palpation, this information will be recorded, but will be excluded from the analysis of Palpator feasibility.
Interventions
DEVICEPalpator
Palpator for tumor localization
DEVICEGrasper
Atraumatic lung grasper
DEVICEUltrasound
VATS ultrasound
OTHERFinger palpation
Palpation of the lung/tumour using the surgeon's finger
Sponsors
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 18 years * Peripheral occult sub-pleural (\>5 mm) solitary lung nodule \< 50 mm on CT scan scheduled for surgical removal using a VATS approach
Exclusion criteria
* Semi-solid nodules (ground glass nodule). * Pregnancy or potentially pregnant women. * Mentally challenged. * Inability to consent for the study. * Patients less than 18 years old. * Patients with pulmonary nodules easily located during VATS (\> 50 mm, pleural puckering, invading chest wall) * Patients who have chest anatomy precluding VATS resection.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tumour detection | 1 day | The palpator will be declared feasible of it can detect at least 80% of tumours (sensitivity) without the need for a thoracotomy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prevention of thoracotomy | 1 day | The number of patients undergoing conversion from VATS to open thoracotomy |
| Adverse events | 30 days | Adverse events will be recorded. |
Contacts
Primary ContactDeb Lewis
Outcome results
None listed