Clinical Evaluation of Vagal Nerve Preservation in Minimally Invasive Surgery for Early Lung Cancer

Study Overview
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Brief Summary
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Through prospective, randomized and controlled clinical study, patients with early lung cancer who do not need lymph node dissection according to routine diagnosis and treatment were selected. The feasibility and safety of preserving vagal pulmonary branch intact during minimally invasive surgery were compared with traditional minimally invasive surgery, and the feasibility and safety of preserving vagal pulmonary branch intact during minimally invasive surgery were clarified. The effect of preserving pulmonary branches of vagus nerve in minimally invasive surgery of early lung cancer on preventing or reducing pulmonary complications after operation was evaluated by main observation indexes (incidence of pulmonary complications) and secondary evaluation indexes. It will provide a safer, simpler and more effective new technology for patients with early lung cancer undergoing minimally invasive surgery, and provide a basis for the popularization of this new technology.

Detailed Description
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According to the suggestion of statistical experts and the minimum sample size, 120 IA1-2 patients who are going to undergo thoracoscopic lung surgery were selected according to the criteria of admission and exclusion. The risk and benefit were informed and the informed consent of the subjects was signed. The patients were numbered and randomly divided into two groups: group A with vagus nerve preservation during minimally invasive surgery and group B with traditional minimally invasive surgery for early lung cancer. The incidence of pulmonary complications within 5 weeks after operation (see the evaluation criteria for details), operation time, intraoperative bleeding volume, postoperative drainage volume, postoperative mortality, incidence of cardiovascular complications, rate of re-tracheal intubation, rate of re-admission to ICU, duration of stay in ICU, hospitalization costs were observed. Statistical analysis and evaluation of the safety of preserving pulmonary branches of vagus nerve in minimally invasive surgery and the effectiveness of preventing or reducing pulmonary complications after minimally invasive surgery.

Official Title
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Clinical Application of Vagus Nerve Preservation in Minimally Invasive Surgery for Early Lung Cancer

Conditions
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Lung Cancer Stage I

Intervention / Treatment
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* Other: In minimally invasive surgery，Vagus nerve preservation
* Other: In minimally invasive surgery，Vagus nerve is not preserved


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: (1) 18-70 years of age, regardless of gender; (2) From May 2019 to December 2021, patients with lung cancer who underwent thoracoscopic pneumonectomy (wedge-shaped, segment and lobe) were admitted to our hospital. Postoperative pathological diagnosis was non-small cell lung cancer. Preoperative pathological staging was T1a-bN0M0 and IA1-2 (pathological staging refers to UICC 8th Edition TNM staging standard for lung cancer). (3) In addition to routine examinations, all patients underwent enhanced chest CT, cranial CT/MRI, abdominal B-mode ultrasound, whole body bone isotope scan or PET-CT to exclude distant metastasis. (4) Subjects clearly understand the purpose of the study, are willing and able to comply with the requirements to complete the study, and sign the informed consent. Exclusion Criteria: (1) Patients with other infectious diseases (inflammation, tuberculosis, etc.) in the thoracic cavity; (2) Patients are unwilling to accept the new technique of preserving pulmonary branch of vagus nerve during operation; (3) Clinical unstable patients with severe cardiovascular, renal and respiratory system; (4) Participated in other clinical trials within 30 days; (5) Other reasons why researchers think it is inappropriate to participate in the experiment.

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
Interventional Model Description: 120 patients were divided into two groups. One group retained the pulmonary vagus nerve and the other group severed the vagus nerve.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Preservation of pulmonary vagus nerve<br>Preservation of pulmonary branches of vagus nerve in minimally invasive surgery for lung cancer | Other: In minimally invasive surgery，Vagus nerve preservation<br>* In minimally invasive surgery for lung cancer, the experimental group retained the pulmonary branches of vagus nerve<br>|
| Experimental: No pulmonary vagus nerve preservation<br>In minimally invasive surgery for lung cancer, the pulmonary branches of vagus nerve were severed | Other: In minimally invasive surgery，Vagus nerve is not preserved<br>* In minimally invasive surgery for lung cancer, the control group did not retain the vagus nerve.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cough after pulmonary resection | (1) dry cough lasting no less than 2 weeks after pneumonectomy; (2) no obvious abnormalities in chest X-ray; (3) excluding drug factors such as postnasal drip syndrome, bronchial asthma and ACEI | From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks. | 
| pulmonary infection | Postoperative pneumonia should be considered if there are three or more of the following indicators: Fever occurred 72 hours after operation, and the body temperature increased again within T > 38 C or 72 hours. Leukocyte count increased (>12-15*109/L) or increased again after the leucocyte count returned to normal value, exceeding 10*109/L; Chest imaging showed consolidation of lung tissue or increasing patchy shadow; cough up purulent sputum or sputum culture positive; If it contains 4, only one of the other items can be considered as a respiratory consultation to determine pulmonary infection, and need to replace antibiotics or prolong the use of antibiotics. | From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks. | 
| Atelectasis | (1) Imaging findings suggest atelectasis or consolidation of the lungs; (2) signs of dyspnea; (3) decreased oxygen saturation to below 90%. | From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks. | 
| hydrothorax | Re-catheterization was needed; dyspnea symptoms; and drainage time was longer than 15 days. | From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks. | 
| Postoperative respiratory failure or ARDS or requiring tracheal intubation | Tracheal intubation; Ventilator; ICU | From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operation time; | Operation time; | From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks. | 
| Intraoperative bleeding volume; | Intraoperative bleeding volume; | From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks. | 
| Postoperative drainage volume; | Postoperative drainage volume; | From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks. | 
| Postoperative mortality | Postoperative mortality | From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks. | 
| Postoperative cardiovascular complications | Postoperative cardiovascular complications | From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks. | 
| Re-admission ICU rate; | Re-admission ICU rate; | From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks. | 
| Time of stay in ICU; | Time of stay in ICU; | From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks. | 
| Hospitalization days | Hospitalization days | From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks. | 
| Hospitalization expenses | Hospitalization expenses | From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks. |