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

NCT ID: NCT04125979

Last Updated: 2019-10-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2022-01-31

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.

Conditions

Lung Cancer Stage I

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Preservation of pulmonary vagus nerve

Preservation of pulmonary branches of vagus nerve in minimally invasive surgery for lung cancer

Group Type: EXPERIMENTAL

In minimally invasive surgery，Vagus nerve preservation

Intervention Type: OTHER

In minimally invasive surgery for lung cancer, the experimental group retained the pulmonary branches of vagus nerve

No pulmonary vagus nerve preservation

In minimally invasive surgery for lung cancer, the pulmonary branches of vagus nerve were severed

Group Type: EXPERIMENTAL

In minimally invasive surgery，Vagus nerve is not preserved

Intervention Type: OTHER

In minimally invasive surgery for lung cancer, the control group did not retain the vagus nerve.

Interventions

In minimally invasive surgery，Vagus nerve preservation

In minimally invasive surgery for lung cancer, the experimental group retained the pulmonary branches of vagus nerve

Intervention Type: 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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Tongji Hospital, Tongji University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Yongxin Zhou

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yongxin zhou, Doctor

Role: STUDY_DIRECTOR

Tongji Hospital affiliated to Tongji University

Locations

Yongxin Zhou

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Wenli Wang, Master's degree

Role: CONTACT

Anderson840913@163.com

13761295864 ext. 86021661110

Yongxin zhou, Doctor

Role: CONTACT

zhou6302@tongji.edu.cn

13681666828

Facility Contacts

Wenli Wang, Master

Role: primary

Anderson840913@163.com

13761295864

Shaorui Gu, scholor

Role: backup

870005908@qq.com

18351977377

References

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.

Reference Type: RESULT

PMID: 26273360 (View on PubMed)

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.

Reference Type: RESULT

PMID: 15620960 (View on PubMed)

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.

Reference Type: RESULT

PMID: 14769722 (View on PubMed)

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.

Reference Type: RESULT

PMID: 27659172 (View on PubMed)

Related Links

http://www.ncbi.nlm.nih.gov/pubmed/?term=2.%09Chen+W%2C+Zheng+R%2C+Zeng+H%2C+et+al.+Epidemiology+of+lung+cancer+in+China.+Thorac+Cancer%2C+2015%2C+6(2)%3A+209-215.

pubmed

https://www.ncbi.nlm.nih.gov/pubmed/?term=Persistent+cough+following+pulmonary+resection%3A+observational+and+empiric+study+of+possible+causes

pubmed

http://www.ncbi.nlm.nih.gov/pubmed/14769722

pubmed

http://www.ncbi.nlm.nih.gov/pubmed/?term=Theperi-esophageal+connective+tissue+layers+and+related+compartments%3A+visualization+by+histology+and+magnetic+resonance+imaging.

pubmed

Other Identifiers

2019-LCYJ-006

Identifier Type: -

Identifier Source: org_study_id