Sequence of Vessel Interruption and Circulating Tumor Cells in Surgical Lung Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Impact of the Sequence of Vessel Interruption During Major Pulmonary Resections for Non-small Cell Lung Cancer Based on Circulating Tumor Cells Detection Peroperatively in the Tumor-draining Pulmonary Vein: a Randomized Pilot Study.

Conditions
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Circulating Tumor Cell, Lung Cancer, Surgery

Intervention / Treatment
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* Procedure: Vein interruption before any other surgical manipulation
* Procedure: Arteries interruption before vein interruption


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vein first<br>Tumor-draining pulmonary vein is interrupted first and before any surgical manipulation. | Procedure: Vein interruption before any other surgical manipulation<br>* 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.<br>|
| Active Comparator: Arteries before vein<br>Lobar arteries (+/- bronchus and inter-lobar fissures) are interrupted before tumor-draining pulmonary vein. | Procedure: Arteries interruption before vein interruption<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in CTC density | 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). | Within 96 hours after surgery | 
| Changes in CTC clusters density | 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). | Within 96 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease free survival | Disease free survival 2 years and 5 years after surgery and recurrence site (local or distant metastasis). | 2 years and 5 years after surgery | 
| Overall survival | Overall survival 2 years and 5 years after surgery. | 2 years and 5 years after surgery |