## Protocol Section
### Identification Module
**NCT ID:** NCT04125979

**Acronym:** CEVNPIMISELC

**Brief Title:** 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

#### Organization Study ID Info
**ID:** 2019-LCYJ-006
#### Organization
**Class:** OTHER
**Full Name:** Shanghai Tongji Hospital, Tongji University School of Medicine
### Status Module
#### Completion Date
**Date:** 2022-01-31

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2019-10-14

**Type:** ACTUAL

**Last Update Submit Date:** 2019-10-11

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2021-01-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2019-01-01

**Type:** ACTUAL

**Status Verified Date:** 2019-10

#### Study First Post Date
**Date:** 2019-10-14
**Type:** ACTUAL
**Study First Submit Date:** 2019-10-05
**Study First Submit QC Date:** 2019-10-11
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Shanghai Tongji Hospital, Tongji University School of Medicine

#### Responsible Party

**Investigator Affiliation:** Shanghai Tongji Hospital, Tongji University School of Medicine

**Investigator Full Name:** Yongxin Zhou

**Investigator Title:** Director

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Lung Cancer Stage I

### Design Module

#### Design Info

**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.

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 120

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Other: In minimally invasive surgery，Vagus nerve preservation

**Label:** Preservation of pulmonary vagus nerve

**Type:** EXPERIMENTAL

#### Arm Group 2

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

**Intervention Names:**

- Other: In minimally invasive surgery，Vagus nerve is not preserved

**Label:** No pulmonary vagus nerve preservation

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Preservation of pulmonary vagus nerve

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

**Name:** In minimally invasive surgery，Vagus nerve preservation

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- No pulmonary vagus nerve preservation

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

**Name:** In minimally invasive surgery，Vagus nerve is not preserved

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** (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

**Measure:** cough after pulmonary resection

**Time Frame:** From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.

**Description:** Postoperative pneumonia should be considered if there are three or more of the following indicators:

1. Fever occurred 72 hours after operation, and the body temperature increased again within T \> 38 C or 72 hours.
2. Leukocyte count increased (\>12-15\*109/L) or increased again after the leucocyte count returned to normal value, exceeding 10\*109/L;
3. Chest imaging showed consolidation of lung tissue or increasing patchy shadow;
4. 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.

**Measure:** pulmonary infection

**Time Frame:** From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.

**Description:** (1) Imaging findings suggest atelectasis or consolidation of the lungs; (2) signs of dyspnea; (3) decreased oxygen saturation to below 90%.

**Measure:** Atelectasis

**Time Frame:** From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.

**Description:** Re-catheterization was needed; dyspnea symptoms; and drainage time was longer than 15 days.

**Measure:** hydrothorax

**Time Frame:** From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.

**Description:** Tracheal intubation; Ventilator; ICU

**Measure:** Postoperative respiratory failure or ARDS or requiring tracheal intubation

**Time Frame:** From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.

#### Secondary Outcomes

**Description:** Operation time;

**Measure:** Operation time;

**Time Frame:** From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.

**Description:** Intraoperative bleeding volume;

**Measure:** Intraoperative bleeding volume;

**Time Frame:** From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.

**Description:** Postoperative drainage volume;

**Measure:** Postoperative drainage volume;

**Time Frame:** From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.

**Description:** Postoperative mortality

**Measure:** Postoperative mortality

**Time Frame:** From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.

**Description:** Postoperative cardiovascular complications

**Measure:** Postoperative cardiovascular complications

**Time Frame:** From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.

**Description:** Re-admission ICU rate;

**Measure:** Re-admission ICU rate;

**Time Frame:** From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.

**Description:** Time of stay in ICU;

**Measure:** Time of stay in ICU;

**Time Frame:** From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.

**Description:** Hospitalization days

**Measure:** Hospitalization days

**Time Frame:** From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.

**Description:** Hospitalization expenses

**Measure:** Hospitalization expenses

**Time Frame:** From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.

### Eligibility Module

**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.

**Maximum Age:** 80 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** Anderson840913@163.com

**Name:** Wenli Wang, Master's degree

**Phone:** 13761295864

**Phone Ext:** 86021661110

**Role:** CONTACT

**Contact 2:**

**Email:** zhou6302@tongji.edu.cn

**Name:** Yongxin zhou, Doctor

**Phone:** 13681666828

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Shanghai

**Contacts:**

***Contact 1:***

- **Email:** Anderson840913@163.com

- **Name:** Wenli Wang, Master

- **Phone:** 13761295864

- **Role:** CONTACT

***Contact 2:***

- **Email:** 870005908@qq.com

- **Name:** Shaorui Gu, scholor

- **Phone:** 18351977377

- **Role:** CONTACT

**Country:** China

**Facility:** Yongxin Zhou

**State:** Shanghai

**Status:** RECRUITING

**Zip:** 200000

#### Overall Officials

**Official 1:**

**Affiliation:** Tongji Hospital affiliated to Tongji University

**Name:** Yongxin zhou, Doctor

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### 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.

**PMID:** 26273360

**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.

**PMID:** 15620960

**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.

**PMID:** 14769722

**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.

**PMID:** 27659172

#### See Also Links

**Label:** pubmed

**URL:** 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.

**Label:** pubmed

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

**Label:** pubmed

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

**Label:** pubmed

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

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012142

- Term: Respiratory Tract Neoplasms

- ID: D000013899

- Term: Thoracic Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000008171

- Term: Lung Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M11172

- Name: Lung Neoplasms

- Relevance: HIGH

- As Found: Lung Cancer

- ID: M14979

- Name: Respiratory Tract Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M16658

- Name: Thoracic Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000008175

- Term: Lung Neoplasms

### Misc Info Module

- Version Holder: 2024-05-24
