Clinical trial NCT04125979: Clinical Evaluation of Vagal Nerve Preservation in Minimally Invasive Surgery for Early Lung Cancer
Official title: Clinical Application of Vagus Nerve Preservation in Minimally Invasive Surgery for Early Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Cancer Stage I
Lead sponsor: Shanghai Tongji Hospital, Tongji University School of Medicine
Sponsor class: OTHER
First posted: 2019-10-14
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 120 patients were divided into two groups. One group retained the pulmonary vagus nerve and the other group severed the vagus nerve.
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: cough after pulmonary resection
timeFrame: From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
measure: pulmonary infection
timeFrame: From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
measure: Atelectasis
timeFrame: From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
measure: hydrothorax
timeFrame: From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
measure: Postoperative respiratory failure or ARDS or requiring tracheal intubation
timeFrame: From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
Secondary outcomes:
measure: Operation time;
timeFrame: From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
measure: Intraoperative bleeding volume;
timeFrame: From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
measure: Postoperative drainage volume;
timeFrame: From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
measure: Postoperative mortality
timeFrame: From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
measure: Postoperative cardiovascular complications
timeFrame: From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
measure: Re-admission ICU rate;
timeFrame: From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
measure: Time of stay in ICU;
timeFrame: From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
measure: Hospitalization days
timeFrame: From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
measure: Hospitalization expenses
timeFrame: From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Yongxin Zhou
state: Shanghai
Study officials:
affiliation: Tongji Hospital affiliated to Tongji University
name: Yongxin zhou, Doctor
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.