Circulating Tumor Cell, Lung Cancer, Surgery
Conditions
Brief summary
This study aims to define the impact of the sequence of vessel interruption on change in CTC and CTC clusters density in the tumor-draining pulmonary vein between the period before surgical manipulation and before tumor-draining vein interruption.
Interventions
PROCEDUREVein interruption before any other surgical manipulation
The pulmonary tumor-drainage vein is first exposed and punctured with a 23-gauge needle, and 7.5 ml of blood is drawn from the pulmonary vein prior to subsequent surgical manipulation for lobectomy. Collected blood is versed in a Cellsearch tube provided by the manufacturer (Menarini Silicon Biosystems, Castel Maggiore, Italy). In the vein first group, the lobar vein is dissected and the cartridge and anvil of a vascular cartridge stapler are placed on either side of the vein. The vein is punctured above the stapler with a 23-gauge needle and 7.5 ml of blood is drawn. Finally, the vein is cut. The intervention then proceeds in the usual manner.
PROCEDUREArteries interruption before vein interruption
The pulmonary tumor-drainage vein is first exposed and punctured with a 23-gauge needle, and 7.5 ml of blood is drawn from the pulmonary vein prior to subsequent surgical manipulation for lobectomy. Collected blood is versed in a Cellsearch tube provided by the manufacturer (Menarini Silicon Biosystems, Castel Maggiore, Italy). In the arteries before vein group, lobar arteries are first dissected and interrupted (+/- the bronchus and inter-lobar fissures). The lobar vein is then dissected and blood sample is performed as described above.
Sponsors
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Laval University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* NSCLC with preoperative pathological evidence, * Pure solid nodule or part-solid (\>50%) ground glass nodule on CT scan * Clinical stage tumor-1 to 3, clinical stage node-0, clinical stage metastasis-0, (except clinical stage tumor-3 for chest wall, pericardium or phrenic nerve invasion) * Video-assisted thoracoscopic lobectomy or bi-lobectomy
Exclusion criteria
* Pneumonectomy, segmentectomy, non anatomic resection * History of thoracic surgery on the same side * Necessity to perform a non-anatomic resection in addition to the lobectomy * No preoperative histological diagnosis * Pure ground glass nodule on CT scan * Clinical stage tumor-4 or 3 for chest wall, pericardium or phrenic nerve invasion * Clinical stage node ≥1 * Neoadjuvant therapy * Second cancer or cancer in the past 5 years * First approach through thoracotomy with ribs spreading * Pregnancy, \<18 years of age * Pulmonary adherences/symphysis found during surgery (impossible to perform the first blood sample without lung manipulation)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in CTC density | Within 96 hours after surgery | Changes in CTC count in 7.5 ml of blood sampled from the tumor-draining vein between the period before surgical manipulation (first sample) and before tumor-draining vein interruption (second sample). |
| Changes in CTC clusters density | Within 96 hours after surgery | Changes in CTC clusters (or CTC micro-emboli defined as ≥3 contiguous CTC) count in 7.5 ml of blood sampled from the tumor-draining vein between the period before surgical manipulation (first sample) and before tumor-draining vein interruption (second sample). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease free survival | 2 years and 5 years after surgery | Disease free survival 2 years and 5 years after surgery and recurrence site (local or distant metastasis). |
| Overall survival | 2 years and 5 years after surgery | Overall survival 2 years and 5 years after surgery. |
Countries
Canada
Contacts
Primary ContactConti Massimo, MD
Backup ContactMarie-Hélène Lavoie
Outcome results
None listed