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| ID | Type | Description | Link |
|---|---|---|---|
| 202510487017 | Other Grant/Funding Number | College Students' Innovative Entrepreneurial Training Plan Program of China |
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Numerous current studies have indicated that transecting the pulmonary plexus nerve as a routine step in radical lung cancer surgery is an independent risk factor for cough hypersensitivity (CH). However, there are significant disagreements in the thoracic surgery community regarding the strategy for managing the vagus pulmonary plexus, primarily because key clinical issues remain unresolved: How do surgical procedures affect the occurrence and development of CH? And how can these procedures be improved?
A large number of published studies have only analyzed "where to cut" while neglecting the surgical issue of "how to cut". Even with a high level of evidence, the conclusions remain contradictory. This is because doctors' preferences and changes in supply conditions can influence the selection of instruments. Differences in the energy of the instruments can lead to varying degrees and scopes of vagus nerve degeneration and collateral damage to the sympathetic pulmonary plexus, while CH is regulated by both the sympathetic and parasympathetic nervous systems.
This project intends to explore the correlation between the selection of surgical instruments and the occurrence and development of postoperative CH at the clinical level, providing a reference for optimizing surgical methods and preventing and treating postoperative CH after lung surgery.
The specific research objectives are: to clarify the correlation through a randomized controlled trial, comparing the patterns and changes in the occurrence and development of postoperative CH between two groups of patients whose autonomic nerve pulmonary plexus was transected using energy-based instruments versus mechanical methods.
Optimize the surgical procedure: Based on the above results, propose a safe, effective, and feasible surgical method to reduce intraoperative damage, prevent postoperative CH, and improve patients' quality of life.
Key problems to be solved: How do surgical operations affect the occurrence and development of CH? How can improvements be made?
Clinical issues:
â‘ Do energy-based instruments (causing thermal damage, etc.) and mechanical transection (causing physical damage), which lead to varying degrees of vagus nerve injury and collateral sympathetic nerve damage, affect the occurrence and development of postoperative cough hypersensitivity (CH)?
â‘¡ How to optimize surgical operations to reduce the incidence of postoperative CH and improve patients' quality of life?
Correlation mechanisms: How do different instruments and energy modes affect the pathophysiology of nerve injury, degeneration, and repair, and what are the correlation patterns and mechanisms between these and the occurrence and development of CH?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Energy Devices Group | Experimental | During the lymph node sampling step, to expose the subcarinal lymph nodes, energy devices (ultrasonic scalpel, electrosurgical knife) will be used to sever the vagus pulmonary plexus. |
|
| Mechanical Transection Group | Active Comparator | During the lymph node sampling step, to expose the subcarinal lymph nodes, mechanical sharp dissection (cutting) will be used to sever the vagus pulmonary plexus. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Energy Device Vagus Nerve Transection | Device | During the lymph node sampling step, to expose the subcarinal lymph nodes, energy devices (ultrasonic scalpel, electrosurgical knife) will be used to sever the vagus pulmonary plexus. |
| Measure | Description | Time Frame |
|---|---|---|
| PC Severity (Perioperative) | Cough Symptom Score (CSS score) is recorded on the day and night of the 7-day follow-up. The median cough symptom score is retrieved 7 days after surgery. 0 is equivalent to no cough during the day/night, while 5 is equivalent to distressing coughs most of the day (or preventing any sleep at night). | Day 1, 2, 3, 4, 5, 6, 7 Post-op |
| PC Pain (Perioperative) | Visual Analog Scale (VAS score) is recorded on the day of follow-up. The median cough symptom score is retrieved on 7 days after surgery. 1 is equivalent to no impact, and 10 is equivalent to the most pain. | Day 1, 2, 3, 4, 5, 6, 7 Post-op |
| PC Incidence Effects on QoL (Preoperative) | The Chinese Mandarin version of the Leicester Cough Questionnaire (LCQ) will be used to compare preoperative and postoperative changes in objective cough frequency and quality of life among patients. It is a 7-point Likert scale with a minimum value of 1, indicating chronic cough impacts participant life all of the time; and a maximum value of 7, indicating chronic cough impacts participant life none of the time. | Day 1 Pre-op |
| Measure | Description | Time Frame |
|---|---|---|
| PC Severity (Postoperative) | Cough Symptom Score (CSS score) is recorded on the day and night follow-up. The median is taken on the day of the follow-up. 0 is equivalent to no cough during the day/night, while 5 is equivalent to distressing coughs most of the day (or preventing any sleep at night). | 30th and 90th day post-op |
| Measure | Description | Time Frame |
|---|---|---|
| Perioperative Thoracic Hemorrhage | Perioperative intravenous hemostatic drugs are used to verify that the surgical procedures of the two groups do not affect the risk of bleeding | During surgery |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shu Peng, Medical Doctor | Contact | +86 18571716422 | drpeng90@hotmail.com | |
| Justin Nathen C Federigan | Contact | +86 15623967709 | dr.justinnathen@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Peng Shu | Department of Thoracic Surgery, Tongji Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | 430030 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38597401 | Background | Ruan ZG, Xu CY, Hua LF. A commentary on 'Pulmonary vagus nerve transection for chronic cough after video-assisted lobectomy: a randomized controlled trial'. Int J Surg. 2024 Jul 1;110(7):4524-4525. doi: 10.1097/JS9.0000000000001428. No abstract available. | |
| 38116674 | Background | Zhang Q, Ge Y, Sun T, Feng S, Zhang C, Hong T, Liu X, Han Y, Cao JL, Zhang H. Pulmonary vagus nerve transection for chronic cough after video-assisted lobectomy: a randomized controlled trial. Int J Surg. 2024 Mar 1;110(3):1556-1563. doi: 10.1097/JS9.0000000000001017. |
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In accordance with the institution's data confidentiality requirements
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| ID | Term |
|---|---|
| C000726768 | cough hypersensitivity syndrome |
| D000096822 | Chronic Cough |
| ID | Term |
|---|---|
| D003371 | Cough |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
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Lymph nodes are grouped according to the standards of the American Joint Committee on Cancer (AJCC) and sampled in accordance with the NCCN Non-Small Cell Lung Cancer Guidelines (2025). In the right thoracic cavity (groups 4, 7, 9, 10, 11), 2 groups of N1 lymph nodes and 2 groups of N2 lymph nodes are sampled.
The posterior mediastinal pleura is opened parallel to the main trunk of the vagus nerve, and the distance between the instrument and the main trunk of the vagus nerve is recorded. During the lymph node sampling step, to expose the subcarinal lymph nodes, energy devices (ultrasonic scalpel, electrosurgical knife) will be used to sever the vagus pulmonary plexus in Group A; while mechanical sharp dissection (cutting) will be used to sever the same plexus in Group B.
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Double-blind controlled trial: The principal investigator goes through the informed consent form with the patients one day before the surgery. The results are randomly grouped and concealed using sealed opaque envelopes. During the surgery, the surgeon opened the envelope, and neither the patients nor the outcome assessors knew about the group allocation. Postoperative follow-up was completed by observers who were also unaware of the group allocation. Bedside interviews were mainly conducted during the patient's hospital stay, while telephone follow-ups or outpatient follow-ups were used to complete the questionnaires 2 to 5 weeks after the surgery.
| Mechanical Vagus Nerve Transection | Device | During the lymph node sampling step, to expose the subcarinal lymph nodes, mechanical sharp dissection (cutting) will be used to sever the vagus pulmonary plexus. |
|
| PC Pain (Postoperative) |
Visual Analog Scale (VAS score) is recorded on the day of follow-up. 1 is equivalent to no impact, and 10 is equivalent to the most pain. |
| 30th and 90th day post-op |
| PC Incidence Effects on QoL (Postoperative) | The Chinese Mandarin version of the Leicester Cough Questionnaire (LCQ) will be used to compare preoperative and postoperative changes in objective cough frequency and quality of life among patients. It is a 7-point Likert scale with a minimum value of 1, indicating chronic cough impacts participant life all of the time; and a maximum value of 7, indicating chronic cough impacts participant life none of the time. | 30th and 90th day post-op |
| Cough Sensitivity Testing | Evaluate the level of cough sensitivity by comparing the intensity of stimulating factors (such as concentration, dose, etc.) or the conditions of cough responses (such as frequency, onset time, etc.) | 30th and 90th day post-op |
| Incidence of Gastrointestinal Complications | Gastrointestinal symptoms include anorexia, belching, reflux, diarrhea, and nausea | Within the 90 days post-op |
| Incidence of Other Complications | Respiratory complications such as pulmonary infection, atelectasis, pulmonary embolism, pleural effusion, postoperative respiratory failure, and the need for tracheal intubation, as well as other systemic complications including arrhythmia, intestinal obstruction, renal failure, and cerebrovascular accident | Within the 30 days post-op |
| Total Number and Stations of Sampled Lymph Nodes | Verify that the surgical procedures of the two groups have no impact on the quality of lymph node sampling | During surgery |
| Surgery Duration | During surgery |
| Intubation Time | Within the 30 days post-op |
| Incidence of Re-hospitalization | Within the 30 days post-op |
| Pulmonary Function Test | FEV1%, FEV1/FVC% (tests to evaluate the impact of vagotomy on lung function) | Pre-op, 30th day post-op, 90th day post-op, 120th day post-op, 360th day post-op |
| 29198796 | Background | Cheng X, Chen H. Commentary on the impacts of postoperative complications on survival after lung cancer surgery. J Thorac Cardiovasc Surg. 2018 Mar;155(3):1265-1266. doi: 10.1016/j.jtcvs.2017.10.122. Epub 2017 Nov 6. No abstract available. |
| 26352410 | Background | Weijs TJ, Ruurda JP, Luyer MD, Nieuwenhuijzen GA, van Hillegersberg R, Bleys RL. Topography and extent of pulmonary vagus nerve supply with respect to transthoracic oesophagectomy. J Anat. 2015 Oct;227(4):431-9. doi: 10.1111/joa.12366. |
| 27279650 | Background | Mazzone SB, Undem BJ. Vagal Afferent Innervation of the Airways in Health and Disease. Physiol Rev. 2016 Jul;96(3):975-1024. doi: 10.1152/physrev.00039.2015. |
| 11240158 | Background | Barnes PJ. Neurogenic inflammation in the airways. Respir Physiol. 2001 Mar;125(1-2):145-54. doi: 10.1016/s0034-5687(00)00210-3. |
| 36170660 | Background | Naqvi KF, Mazzone SB, Shiloh MU. Infectious and Inflammatory Pathways to Cough. Annu Rev Physiol. 2023 Feb 10;85:71-91. doi: 10.1146/annurev-physiol-031422-092315. Epub 2022 Sep 28. |
| 39768967 | Background | Kepicova M, Tulinsky L, Konde A, Dzurnakova P, Ihnat P, Adamica D, Neoral C, Martinek L. Risk Factors and Postoperative Complications of Lobectomy for Non-Small Cell Lung Cancer: An Exploratory Analysis of Premedication and Clinical Variables. Medicina (Kaunas). 2024 Dec 20;60(12):2088. doi: 10.3390/medicina60122088. |
| 22958367 | Background | Polverino M, Polverino F, Fasolino M, Ando F, Alfieri A, De Blasio F. Anatomy and neuro-pathophysiology of the cough reflex arc. Multidiscip Respir Med. 2012 Jun 18;7(1):5. doi: 10.1186/2049-6958-7-5. |
| 37920959 | Background | Sun X, Lan Z, Li S, Huang S, Zeng C, Wu J, Chen Q, Chen Y, Chen Z, Tang Y, Qiao G. Trajectories and risk factors of persistent cough after pulmonary resection: A prospective two-center study. Thorac Cancer. 2023 Dec;14(36):3503-3510. doi: 10.1111/1759-7714.15147. Epub 2023 Nov 3. |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |