Lung Cancer Stage ICEVNPIMISELCNCT04125979
Clinical Evaluation of Vagal Nerve Preservation in Minimally Invasive Surgery for Early Lung Cancer
A study testing In minimally invasive surgery，Vagus nerve preservation and In minimally invasive surgery，Vagus nerve is not preserved in people with Lung Cancer Stage I, run by Shanghai Tongji Hospital, Tongji University School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lung Cancer Stage I
- What is being tested?
- In minimally invasive surgery，Vagus nerve preservation and In minimally invasive surgery，Vagus nerve is not preserved
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 31 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (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.
Who cannot join
- (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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Yongxin Zhou
Shanghai, Shanghai Municipality, 200000
Wenli Wang, Master, 13761295864, Anderson840913@163.com
Shaorui Gu, scholor, 18351977377, 870005908@qq.com
About this study
Official title: Clinical Application of Vagus Nerve Preservation in Minimally Invasive Surgery for Early Lung Cancer
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.
Read the 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
- Being tested
- In minimally invasive surgery，Vagus nerve preservation, In minimally invasive surgery，Vagus nerve is not preserved
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In minimally invasive surgery，Vagus nerve preservationOther
In minimally invasive surgery for lung cancer, the experimental group retained the pulmonary branches of 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.
| Study group | Role | What they receive |
|---|---|---|
| Preservation of pulmonary vagus nerve | Experimental | Preservation of pulmonary branches of vagus nerve in minimally invasive surgery for lung cancer Receives: 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 Receives: Other: In minimally invasive surgery，Vagus nerve is not preserved |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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:
- 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.
Measured: 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%.
Measured: 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.
Measured: 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
Measured: 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;
Operation time;
Measured: From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
Intraoperative bleeding volume;
Intraoperative bleeding volume;
Measured: From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
Postoperative drainage volume;
Postoperative drainage volume;
Measured: From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
Postoperative mortality
Postoperative mortality
Measured: From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
Postoperative cardiovascular complications
Postoperative cardiovascular complications
Measured: From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
Re-admission ICU rate;
Re-admission ICU rate;
Measured: From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
Time of stay in ICU;
Time of stay in ICU;
Measured: From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
Hospitalization days
Hospitalization days
Measured: From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
Hospitalization expenses
Hospitalization expenses
Measured: From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2019
- Study start1 Jan 2019
- Primary completion30 Jan 2021 (estimated)
- Study completion31 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Lung Cancer Stage IStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Tongji Hospital, Tongji University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongxin Zhou, Shanghai Tongji Hospital, Tongji University School of Medicine
- Investigators
- Yongxin zhou, Doctor, Study director, Dongfang Hospital Affiliated to Tongji University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04125979
- Sponsor's protocol ID
- 2019-LCYJ-006
- Acronym
- CEVNPIMISELC
- Status last verified
- Oct 2019
- First submitted
- 5 Oct 2019
- Last updated
- 14 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26273360Sawabata 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.
PubMed 15620960Sarna 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.
PubMed 14769722Weijs 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.
PubMed 27659172
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Application of Vagus Nerve Preservation in Minimally Invasive Surgery for Early Lung Cancer
- ClinicalTrials.gov ID
- NCT04125979
- Acronym / sponsor ID
- CEVNPIMISELC / 2019-LCYJ-006
- Conditions
- Lung Cancer Stage I
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Shanghai Tongji Hospital, Tongji University School of MedicineUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Jan 2021 (estimated)
- Study completion
- 31 Jan 2022 (estimated)
- First posted
- 14 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 120 patients were divided into two groups. One group retained the pulmonary vagus nerve and the other group severed the vagus nerve.
| Arm | Type | Receives |
|---|---|---|
| Preservation of pulmonary vagus nerve | Experimental | Other: In minimally invasive surgery，Vagus nerve preservationPreservation of pulmonary branches of vagus nerve in minimally invasive surgery for lung cancer |
| No pulmonary vagus nerve preservation | Experimental | Other: In minimally invasive surgery，Vagus nerve is not preservedIn minimally invasive surgery for lung cancer, the pulmonary branches of vagus nerve were severed |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- (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.
Key exclusion criteria (5 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In minimally invasive surgery，Vagus nerve preservationIn minimally invasive surgery for lung cancer, the experimental group retained the pulmonary branches of vagus nerve | Other | Preservation of pulmonary vagus nerve |
| In minimally invasive surgery，Vagus nerve is not preservedIn minimally invasive surgery for lung cancer, the control group did not retain the vagus nerve. | Other | No pulmonary vagus nerve preservation |
Primary outcome
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.
(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
Time frame: From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
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.
Atelectasis
Time frame: From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
(1) Imaging findings suggest atelectasis or consolidation of the lungs; (2) signs of dyspnea; (3) decreased oxygen saturation to below 90%.
hydrothorax
Time frame: From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
Re-catheterization was needed; dyspnea symptoms; and drainage time was longer than 15 days.
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.
Tracheal intubation; Ventilator; ICU
9 secondary outcomes
Operation time;
Time frame: From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
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.
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.
Postoperative mortality
Time frame: From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
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.
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.
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.
Hospitalization days
Time frame: From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
Hospitalization expenses
Time frame: From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2019.
- Results publication: PubMed 26273360Chen 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 publication: PubMed 15620960Sawabata 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 publication: PubMed 14769722Sarna 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 publication: PubMed 27659172Weijs 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.
- pubmedLink provided by the sponsor.
- pubmedLink provided by the sponsor.
- pubmedLink provided by the sponsor.
- pubmedLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yongxin zhou, Doctor study director
Dongfang Hospital Affiliated to Tongji University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In minimally invasive surgery，Vagus nerve preservation and In minimally invasive surgery，Vagus nerve is not preserved in people with Lung Cancer Stage I, run by Shanghai Tongji Hospital, Tongji University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wenli Wang, Master's degree (13761295864 ext. 86021661110, Anderson840913@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04125979, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2019.