NCT04125979

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 5, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 14, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2022

Completed
Last Updated

October 14, 2019

Status Verified

October 1, 2019

Enrollment Period

2.1 years

First QC Date

October 5, 2019

Last Update Submit

October 11, 2019

Conditions

Lung Cancer Stage I

Outcome Measures

Primary Outcomes (5)

  • 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: 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.

    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 Outcomes (9)

  • 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;

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

  • 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

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

  • Postoperative cardiovascular complications

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

  • +4 more secondary outcomes

Study Arms (2)

Preservation of pulmonary vagus nerve

EXPERIMENTAL

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

Other: In minimally invasive surgery，Vagus nerve preservation

No pulmonary vagus nerve preservation

EXPERIMENTAL

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

Interventions

In minimally invasive surgery，Vagus nerve preservationOTHER

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

Preservation of pulmonary vagus nerve
In minimally invasive surgery，Vagus nerve is not preservedOTHER

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

No pulmonary vagus nerve preservation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • (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.

You may not qualify if:

  • (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yongxin Zhou

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

Related Publications (4)

  • 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: 26273360RESULT

  • 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: 15620960RESULT

  • 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: 14769722RESULT

  • 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: 27659172RESULT

Related Links

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Yongxin zhou, Doctor

    Tongji Hospital affiliated to Tongji University

    STUDY DIRECTOR

Central Study Contacts

Wenli Wang, Master's degree

CONTACT

13761295864Anderson840913@163.com

Yongxin zhou, Doctor

CONTACT

13681666828zhou6302@tongji.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 120 patients were divided into two groups. One group retained the pulmonary vagus nerve and the other group severed the vagus nerve.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

October 5, 2019

First Posted

October 14, 2019

Study Start

January 1, 2019

Primary Completion

January 30, 2021

Study Completion

January 31, 2022

Last Updated

October 14, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)