Reduced Dissemination of Tumor Cells With Primary Ligation of the Vein in Patients With Lung Cancer

Study Overview
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Brief Summary
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The purpose of this study is to assess the impact of the sequence of vessel interruption in lung cancer patients on tumor cell spread and patient survival by using peripheral blood circulating tumor cells.

Detailed Description
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Circulating tumor cells (CTCs) in the peripheral blood can be a biomarker to predict tumor recurrence and survival. Handling the tumor during a surgery may promote the release of CTCs into the bloodstream. Therefore, in a surgery of cancer, interruption of the vein before ligation of the artery may be justified. This multi-center randomized controlled trial is to assess the impact of the sequence of vessel interruption in lung cancer patients on tumor cell spread and patient survival by using peripheral blood CTCs.

Official Title
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Reduced Dissemination of Tumor Cells With Primary Ligation of the Vein in Patients With Lung Cancer: A Multi-centre Randomized Controlled Trial

Conditions
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Surgery, Lung Cancer, Circulating Tumor Cell

Intervention / Treatment
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* Procedure: Vein ligation first
* Procedure: Artery ligation first


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with stage I-IV lung cancer eligible for surgery Patients undergoing the completely thoracoscopic lobectomy The nodule size was more than 2.5 cm Patients consenting for intraoperative blood sampling Exclusion Criteria: Patients who underwent primary wedge resection and open lobectomy Patients who received neoadjuvant therapy before surgery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vein ligation first<br>During this procedure, patients undergo lobectomy with the pulmonary vein ligated first. | Procedure: Vein ligation first<br>* During this procedure, patients undergo lobectomy with the pulmonary vein ligated first.<br>|
| Active Comparator: Artery ligation first<br>During this procedure, patients undergo lobectomy with the pulmonary artery ligated first. | Procedure: Artery ligation first<br>* During this procedure, patients undergo lobectomy with the pulmonary artery ligated first.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The changes of the level of circulating tumor cells in the peripheral blood | The changes of the level of circulating tumor cells in the peripheral blood before cutting the skin and after closing the chest | Intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-year Progression-Free-Survival | From the date of recruitment until the date of progression of lung cancer assessed up to 36 months | From date of the recruitment, assessed up to 36 months | 
| Blood loss | Blood loss during the surgery | During the surgery | 
| Operative time | Operative time during the surgery | During the surgery | 
| Length of stay | The length of patients staying in hospital from the date of checking in to the date of checking out | From date of admission until the date of discharging or date of death from any cause in hospital, whichever came first, assessed up to 30 days | 
| Morbidity | Complications resulting from surgery, such as pneumonia, air leak and arrhythmia. | Within 30 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung cancer, Surgical technique, vessel ligation, Circulating tumor cell