Clinical trial · Interventional
Vagus Nerve Preservation and Chronic Cough in Non-small Cell Lung Cancer Surgery
Prospective Randomized Controlled Study on the Effects of Vagus Nerve Pulmonary Branch Preservation During Video-assisted Thoracic Surgery Lobectomy in Non-small Cell Lung Cancer: Can it Decrease Postoperative Cough and Pulmonary Complications
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Lung cancer is the leading cause of cancer death worldwide. Surgical resection is the main treatment for resectable non-small-cell lung cancer (NSCLC), and lobectomy with systemic mediastinal lymph node dissection is the standard surgical method. However, a significant number of patients experience postoperative chronic cough; it is observed in about 60% of patients during the first year of outpatient clinic follow-up, and persistently lasts in about 24.7-50% during the 5 year follow-up period. Several studies showed the association between vagus nerve and chronic cough. The bronchopulmonary vagal afferent C-fibers are responsible for cough, chest tightness and reflex bronchoconstrictions. It is expected that during the mediastinal lymph node dissection, the inevitable injuries to the pulmonary branch of vagus nerve is largely responsible for development of chronic cough. In other words, preservation of pulmonary branch of vagus nerve may reduce the incidence of chronic cough and relevant detrimental effects on quality of life. Therefore, this prospective, randomized and controlled clinical study, aims to evaluate the effect of vagus nerve preservation on postoperative chronic cough in patients undergoing lobectomy with mediastinal lymph node dissection. In addition, the feasibility and oncologic safety of preserving pulmonary branch of vagus nerve during mediastinal lymph node dissection with minimally invasive surgery compared with conventional mediastinal lymph node dissection with minimally invasive surgery will also be investigated. This trial will provide a new basis for oncologically feasible, safe and effective new surgical technique for mediastinal lymph node dissection in patients with early lung cancer undergoing minimally invasive surgery. Furthermore, the preventive effect of vagus nerve preservation on incidence of chronic cough will be objectively be proven and thus help to broaden the current knowledge of the role of vagus nerve and postoperative chronic cough.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cough | — | UNRESOLVED | — |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Vagus Nerve Injuries | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pulmonary branch of vagus nerve not preserved | Procedure | — | UNRESOLVED |
| Pulmonary branch of vagus nerve preserved | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Pulmonary branch of vagus nerve preserved
- description
- Pulmonary branch of vagus nerve is preserved during the mediastinal lymph node dissection using minimally invasive surgery
- interventionNames
- Procedure: Pulmonary branch of vagus nerve preserved
- type
- EXPERIMENTAL
- label
- Pulmonary branch of vagus nerve not-preserved
- description
- Pulmonary branch of vagus nerve is not preserved during the mediastinal lymph node dissection using minimally invasive surgery
- interventionNames
- Procedure: Pulmonary branch of vagus nerve not preserved
Primary outcomes (12)
- measure
- Qualitative measurement of postoperative cough
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Subjects clearly understand the purpose of the study, are willing and able to comply with the requirements to complete the study, and can sign the informed consent. 2. Clinically suspicious of non-small cell lung cancer or tissue confirmed preoperatively 3. Clinical stage T1-3/N0-1/M0 4. Preoperative ECOG performance status 0-1 5. Preoperative ASA class I-III 6. Preoperative pulmonary function test FEV1 ≥ 60%, DLCO ≥ 60% 7. Patients expected to achieve R0 (complete resection) via simple lobectomy and mediastinal lymph node dissection Exclusion Criteria: 1. Patients who smoked within 2 weeks prior to operation 2. Patients who received antitussives and expectorants 2 weeks prior to operation 3. Patients who are pregnant or breast feeding 4. Patients with severe or uncontrolled psychological disorders 5. Patients with severe pulmonary adhesion 6. Patients who are ineligible for minimally invasive surgery; thoracotomy conversion 7. Patients diagnosed with other malignancies within 2 years prior to operation 8. Patients who received chemotherapy or radiotherapy within 6 months prior to operation 9. Patients suspicious of clinical N2 or received neoadjuvant therapy prior to operation 10. Patients with cough-related diseases; COPD, asthma, ILD, GERD 11. Patients suspicious of lymph node metastasis/invasion around vagus nerve during the preoperative clinical staging evaluation
References
Publications (13)
- BACKGROUNDKwon JW, Moon JY, Kim SH, Song WJ, Kim MH, Kang MG, Lim KH, Lee SH, Lee SM, Lee JY, Kwon HS, Kim KM, Kim SH, Kim SH, Jeong JW, Kim CW, Cho SH, Lee BJ; Work Group for Chronic Cough, the Korean Academy of Asthma, Allergy and Clinical Immunology. Reliability and validity of a korean version of the leicester cough questionnaire. Allergy Asthma Immunol Res. 2015 May;7(3):230-3. doi: 10.4168/aair.2015.7.3.230. Epub 2014 Dec 18. PMID 25749761
- BACKGROUNDAl-Shamlan F, El-Hashim AZ. Bradykinin sensitizes the cough reflex via a B2 receptor dependent activation of TRPV1 and TRPA1 channels through metabolites of cyclooxygenase and 12-lipoxygenase. Respir Res. 2019 Jun 6;20(1):110. doi: 10.1186/s12931-019-1060-8. PMID 31170972
- BACKGROUNDChen S, Huang S, Yu S, Han Z, Gao L, Shen Z, Kang M. The clinical value of a new method of functional lymph node dissection in video-assisted thoracic surgery right non-small cell lung cancer radical resection. J Thorac Dis. 2019 Feb;11(2):477-487. doi: 10.21037/jtd.2019.01.15. PMID 30962991
- BACKGROUNDHuang J, Luo Q, Tan Q, Lin H, Qian L, Ding Z. Evaluation of the surgical fat-filling procedure in the treatment of refractory cough after systematic mediastinal lymphadenectomy in patients with right lung cancer. J Surg Res. 2014 Apr;187(2):490-5. doi: 10.1016/j.jss.2013.10.062. Epub 2013 Nov 5. PMID 24300131
- BACKGROUNDLin R, Che G. Risk factors of cough in non-small cell lung cancer patients after video-assisted thoracoscopic surgery. J Thorac Dis. 2018 Sep;10(9):5368-5375. doi: 10.21037/jtd.2018.08.54. PMID 30416784
- BACKGROUNDLiu Z, Liu Y, Xie C, Yang J, Zeng B, Yeung SJ, Cheng C. Vagus nerve and phrenic nerve guided systematic nodal dissection for lung cancer. J Thorac Dis. 2019 Sep;11(9):4021-4027. doi: 10.21037/jtd.2019.08.80. No abstract available. PMID 31656677
- Poghosyan H, Sheldon LK, Leveille SG, Cooley ME. Health-related quality of life after surgical treatment in patients with non-small cell lung cancer: a systematic review. Lung Cancer. 2013 Jul;81(1):11-26. doi: 10.1016/j.lungcan.2013.03.013. Epub 2013 Apr 4.