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

Primary Purpose

Lung Cancer Stage I

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
In minimally invasive surgery，Vagus nerve preservation
In minimally invasive surgery，Vagus nerve is not preserved
Sponsored by
Shanghai Tongji Hospital, Tongji University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer Stage I

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Yongxin ZhouRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Preservation of pulmonary vagus nerve

No pulmonary vagus nerve preservation

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
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.
Atelectasis
(1) Imaging findings suggest atelectasis or consolidation of the lungs; (2) signs of dyspnea; (3) decreased oxygen saturation to below 90%.
hydrothorax
Re-catheterization was needed; dyspnea symptoms; and drainage time was longer than 15 days.
Postoperative respiratory failure or ARDS or requiring tracheal intubation
Tracheal intubation; Ventilator; ICU

Secondary Outcome Measures

Operation time;
Operation time;
Intraoperative bleeding volume;
Intraoperative bleeding volume;
Postoperative drainage volume;
Postoperative drainage volume;
Postoperative mortality
Postoperative mortality
Postoperative cardiovascular complications
Postoperative cardiovascular complications
Re-admission ICU rate;
Re-admission ICU rate;
Time of stay in ICU;
Time of stay in ICU;
Hospitalization days
Hospitalization days
Hospitalization expenses
Hospitalization expenses

Full Information

First Posted
October 5, 2019
Last Updated
October 11, 2019
Sponsor
Shanghai Tongji Hospital, Tongji University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04125979
Brief Title
Clinical Evaluation of Vagal Nerve Preservation in Minimally Invasive Surgery for Early Lung Cancer
Acronym
CEVNPIMISELC
Official Title
Clinical Application of Vagus Nerve Preservation in Minimally Invasive Surgery for Early Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
January 30, 2021 (Anticipated)
Study Completion Date
January 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Tongji Hospital, Tongji University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer Stage I

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Preservation of pulmonary vagus nerve
Arm Type
Experimental
Arm Description
Preservation of pulmonary branches of vagus nerve in minimally invasive surgery for lung cancer
Arm Title
No pulmonary vagus nerve preservation
Arm Type
Experimental
Arm Description
In minimally invasive surgery for lung cancer, the pulmonary branches of vagus nerve were severed
Intervention Type
Other
Intervention Name(s)
In minimally invasive surgery，Vagus nerve preservation
Intervention Description
In minimally invasive surgery for lung cancer, the experimental group retained the pulmonary branches of vagus nerve
Intervention Type
Other
Intervention Name(s)
In minimally invasive surgery，Vagus nerve is not preserved
Intervention Description
In minimally invasive surgery for lung cancer, the control group did not retain the vagus nerve.
Primary Outcome Measure Information:
Title
cough after pulmonary resection
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
Time Frame
From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
Title
pulmonary infection
Description
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.
Time Frame
From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
Title
Atelectasis
Description
(1) Imaging findings suggest atelectasis or consolidation of the lungs; (2) signs of dyspnea; (3) decreased oxygen saturation to below 90%.
Time Frame
From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
Title
hydrothorax
Description
Re-catheterization was needed; dyspnea symptoms; and drainage time was longer than 15 days.
Time Frame
From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
Title
Postoperative respiratory failure or ARDS or requiring tracheal intubation
Description
Tracheal intubation; Ventilator; ICU
Time Frame
From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
Secondary Outcome Measure Information:
Title
Operation time;
Description
Operation time;
Time Frame
From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
Title
Intraoperative bleeding volume;
Description
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.
Title
Postoperative drainage volume;
Description
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.
Title
Postoperative mortality
Description
Postoperative mortality
Time Frame
From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
Title
Postoperative cardiovascular complications
Description
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.
Title
Re-admission ICU rate;
Description
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.
Title
Time of stay in ICU;
Description
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.
Title
Hospitalization days
Description
Hospitalization days
Time Frame
From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
Title
Hospitalization expenses
Description
Hospitalization expenses
Time Frame
From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wenli Wang, Master's degree
Phone
13761295864
Ext
86021661110
Email
Anderson840913@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yongxin zhou, Doctor
Phone
13681666828
Email
zhou6302@tongji.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yongxin zhou, Doctor
Organizational Affiliation
Tongji Hospital Affiliated to Tongji University
Official's Role
Study Director
Facility Information:
Facility Name
Yongxin Zhou
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenli Wang, Master
Phone
13761295864
Email
Anderson840913@163.com
First Name & Middle Initial & Last Name & Degree
Shaorui Gu, scholor
Phone
18351977377
Email
870005908@qq.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26273360
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.
Results Reference
result
PubMed Identifier
15620960
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.
Results Reference
result
PubMed Identifier
14769722
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.
Results Reference
result
PubMed Identifier
27659172
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.
Results Reference
result
Links:
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.
Description
pubmed
URL
https://www.ncbi.nlm.nih.gov/pubmed/?term=Persistent+cough+following+pulmonary+resection%3A+observational+and+empiric+study+of+possible+causes
Description
pubmed
URL
http://www.ncbi.nlm.nih.gov/pubmed/14769722
Description
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.
Description
pubmed

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

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