Circulating Tumor Cell, Lung Cancer, Surgery
Conditions
Keywords
Lung cancer, Surgical technique, vessel ligation, Circulating tumor cell
Brief summary
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
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.
Interventions
PROCEDUREVein ligation first
During this procedure, patients undergo lobectomy with the pulmonary vein ligated first.
PROCEDUREArtery ligation first
During this procedure, patients undergo lobectomy with the pulmonary artery ligated first.
Sponsors
West China Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with stage I-IV lung cancer eligible for surgery 2. Patients undergoing the completely thoracoscopic lobectomy 3. The nodule size was more than 2.5 cm 4. Patients consenting for intraoperative blood sampling
Exclusion criteria
1. Patients who underwent primary wedge resection and open lobectomy 2. Patients who received neoadjuvant therapy before surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The changes of the level of circulating tumor cells in the peripheral blood | Intraoperative | The changes of the level of circulating tumor cells in the peripheral blood before cutting the skin and after closing the chest |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of stay | 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 | The length of patients staying in hospital from the date of checking in to the date of checking out |
| Morbidity | Within 30 days after surgery | Complications resulting from surgery, such as pneumonia, air leak and arrhythmia. |
| 3-year Progression-Free-Survival | From date of the recruitment, assessed up to 36 months | From the date of recruitment until the date of progression of lung cancer assessed up to 36 months |
| Blood loss | During the surgery | Blood loss during the surgery |
| Operative time | During the surgery | Operative time during the surgery |
Countries
China
Outcome results
None listed