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

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

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.

Study Overview

• Status: Unknown
• Conditions: Lung Cancer Stage I
• Intervention / Treatment: Other: In minimally invasive surgery，Vagus nerve preservation; Other: In minimally invasive surgery，Vagus nerve is not preserved

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200000
      • Recruiting
      • Yongxin Zhou
      • Contact: Wenli Wang, Master; Phone Number: 13761295864; Email: Anderson840913@163.com
      • Contact: Shaorui Gu, scholor; Phone Number: 18351977377; Email: 870005908@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Preservation of pulmonary vagus nerve; Preservation of pulmonary branches of vagus nerve in minimally invasive surgery for lung cancer	Other: In minimally invasive surgery，Vagus nerve preservation; In minimally invasive surgery for lung cancer, the experimental group retained the pulmonary branches of vagus nerve
Experimental: No pulmonary vagus nerve preservation; 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; In minimally invasive surgery for lung cancer, the control group did not retain the vagus nerve.

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Shanghai Tongji Hospital, Tongji University School of Medicine
• Investigators: Study Director: Yongxin zhou, Doctor, Tongji Hospital Affiliated to Tongji University

Publications and helpful links

General Publications

• Chen W, Zheng R, Zeng H, Zhang S. Epidemiology of lung cancer in China. Thorac Cancer. 2015 Mar;6(2):209-15. doi: 10.1111/1759-7714.12169. Epub 2015 Mar 2.
• Sawabata N, Maeda H, Takeda S, Inoue M, Koma M, Tokunaga T, Matsuda H. Persistent cough following pulmonary resection: observational and empiric study of possible causes. Ann Thorac Surg. 2005 Jan;79(1):289-93. doi: 10.1016/j.athoracsur.2004.06.045.
• Sarna L, Evangelista L, Tashkin D, Padilla G, Holmes C, Brecht ML, Grannis F. Impact of respiratory symptoms and pulmonary function on quality of life of long-term survivors of non-small cell lung cancer. Chest. 2004 Feb;125(2):439-45. doi: 10.1378/chest.125.2.439.
• Weijs TJ, Goense L, van Rossum PSN, Meijer GJ, van Lier AL, Wessels FJ, Braat MN, Lips IM, Ruurda JP, Cuesta MA, van Hillegersberg R, Bleys RL. The peri-esophageal connective tissue layers and related compartments: visualization by histology and magnetic resonance imaging. J Anat. 2017 Feb;230(2):262-271. doi: 10.1111/joa.12552. Epub 2016 Sep 23.

Helpful Links

• pubmed
• pubmed
• pubmed
• pubmed

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Anticipated): January 30, 2021
• Study Completion (Anticipated): January 31, 2022

Study Registration Dates

• First Submitted: October 5, 2019
• First Submitted That Met QC Criteria: October 11, 2019
• First Posted (Actual): October 14, 2019

Study Record Updates

• Last Update Posted (Actual): October 14, 2019
• Last Update Submitted That Met QC Criteria: October 11, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 2019-LCYJ-006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No