Vagus Nerve Preservation and Chronic Cough in Non-small Cell Lung Cancer Surgery
24 ottobre 2022 aggiornato da: Kwhanmien Kim, Seoul National University Bundang Hospital
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
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.
Panoramica dello studio
Stato
Reclutamento
Condizioni
Tipo di studio
Interventistico
Iscrizione (Anticipato)
214
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Kwhanmien Kim, MD. PhD
- Numero di telefono: +82-31-787-7130
- Email: kmkim0070@snubh.org
Luoghi di studio
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Bundang
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Seongnam-si, Bundang, Corea, Repubblica di, 13620
- Reclutamento
- Seoul National University
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Contatto:
- Beatrice C Shih, MD
- Numero di telefono: 821091094533
- Email: 82430@snubh.org
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Investigatore principale:
- Kwhanmien Kim, MD.PhD.
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 80 anni (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
- 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.
- Clinically suspicious of non-small cell lung cancer or tissue confirmed preoperatively
- Clinical stage T1-3/N0-1/M0
- Preoperative ECOG performance status 0-1
- Preoperative ASA class I-III
- Preoperative pulmonary function test FEV1 ≥ 60%, DLCO ≥ 60%
- Patients expected to achieve R0 (complete resection) via simple lobectomy and mediastinal lymph node dissection
Exclusion Criteria:
- Patients who smoked within 2 weeks prior to operation
- Patients who received antitussives and expectorants 2 weeks prior to operation
- Patients who are pregnant or breast feeding
- Patients with severe or uncontrolled psychological disorders
- Patients with severe pulmonary adhesion
- Patients who are ineligible for minimally invasive surgery; thoracotomy conversion
- Patients diagnosed with other malignancies within 2 years prior to operation
- Patients who received chemotherapy or radiotherapy within 6 months prior to operation
- Patients suspicious of clinical N2 or received neoadjuvant therapy prior to operation
- Patients with cough-related diseases; COPD, asthma, ILD, GERD
- Patients suspicious of lymph node metastasis/invasion around vagus nerve during the preoperative clinical staging evaluation
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Pulmonary branch of vagus nerve preserved
Pulmonary branch of vagus nerve is preserved during the mediastinal lymph node dissection using minimally invasive surgery
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During the mediastinal lymph node dissection using minimally invasive surgery, efforts to preserve the pulmonary branch of vagus nerve is made.
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Sperimentale: Pulmonary branch of vagus nerve not-preserved
Pulmonary branch of vagus nerve is not preserved during the mediastinal lymph node dissection using minimally invasive surgery
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During the mediastinal lymph node dissection using minimally invasive surgery, efforts to preserve the pulmonary branch of vagus nerve is not made/ can be severed.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Qualitative measurement of postoperative cough
Lasso di tempo: Preoperative day
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Cough Visual Analog Scale (VAS) will be used for survey.
The Cough VAS is a numeric scale from 0-10 scale, with 0 indicating that patient experiences no distress from cough and 10 indicating severe distress from cough.
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Preoperative day
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Qualitative measurement of postoperative cough
Lasso di tempo: Postoperative day (discharge day, an average of 1 week)
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Cough Visual Analog Scale (VAS) will be used for survey.
The Cough VAS is a numeric scale from 0-10 scale, with 0 indicating that patient experiences no distress from cough and 10 indicating severe distress from cough.
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Postoperative day (discharge day, an average of 1 week)
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Qualitative measurement of postoperative cough
Lasso di tempo: Postoperative 1 month follow up at outpatient clinic
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Cough Visual Analog Scale (VAS) will be used for survey.
The Cough VAS is a numeric scale from 0-10 scale, with 0 indicating that patient experiences no distress from cough and 10 indicating severe distress from cough.
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Postoperative 1 month follow up at outpatient clinic
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Qualitative measurement of postoperative cough
Lasso di tempo: Postoperative 2 month follow up at outpatient clinic
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Cough Visual Analog Scale (VAS) will be used for survey.
The Cough VAS is a numeric scale from 0-10 scale, with 0 indicating that patient experiences no distress from cough and 10 indicating severe distress from cough.
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Postoperative 2 month follow up at outpatient clinic
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Qualitative measurement of postoperative cough
Lasso di tempo: Postoperative 6 month follow up at outpatient clinic
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Cough Visual Analog Scale (VAS) will be used for survey.
The Cough VAS is a numeric scale from 0-10 scale, with 0 indicating that patient experiences no distress from cough and 10 indicating severe distress from cough.
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Postoperative 6 month follow up at outpatient clinic
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Qualitative measurement of postoperative cough
Lasso di tempo: Postoperative 12 month follow up at outpatient clinic
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Cough Visual Analog Scale (VAS) will be used for survey.
The Cough VAS is a numeric scale from 0-10 scale, with 0 indicating that patient experiences no distress from cough and 10 indicating severe distress from cough.
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Postoperative 12 month follow up at outpatient clinic
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Quantitative measurement of postoperative cough
Lasso di tempo: Preoperative day
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The Korean version of the Leicester Cough Questionnaire will be used for survey.
Comparison of preoperative and and postoperative change in objective cough frequency and quality of life among patients using the Leicester Cough Questionnaire, which 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.
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Preoperative day
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Quantitative measurement of postoperative cough
Lasso di tempo: Postoperative day (discharge day, an average of 1 week)
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The Korean version of the Leicester Cough Questionnaire will be used for survey.
Comparison of preoperative and and postoperative change in objective cough frequency and quality of life among patients using the Leicester Cough Questionnaire, which 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.
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Postoperative day (discharge day, an average of 1 week)
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Quantitative measurement of postoperative cough
Lasso di tempo: Postoperative 1 month follow up at outpatient clinic
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The Korean version of the Leicester Cough Questionnaire will be used for survey.
Comparison of preoperative and and postoperative change in objective cough frequency and quality of life among patients using the Leicester Cough Questionnaire, which 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.
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Postoperative 1 month follow up at outpatient clinic
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Quantitative measurement of postoperative cough
Lasso di tempo: Postoperative 2 month follow up at outpatient clinic
|
The Korean version of the Leicester Cough Questionnaire will be used for survey.
Comparison of preoperative and and postoperative change in objective cough frequency and quality of life among patients using the Leicester Cough Questionnaire, which 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.
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Postoperative 2 month follow up at outpatient clinic
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Quantitative measurement of postoperative cough
Lasso di tempo: Postoperative 6 month follow up at outpatient clinic
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The Korean version of the Leicester Cough Questionnaire will be used for survey.
Comparison of preoperative and and postoperative change in objective cough frequency and quality of life among patients using the Leicester Cough Questionnaire, which 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.
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Postoperative 6 month follow up at outpatient clinic
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Quantitative measurement of postoperative cough
Lasso di tempo: Postoperative 12 month follow up at outpatient clinic
|
The Korean version of the Leicester Cough Questionnaire will be used for survey.
Comparison of preoperative and and postoperative change in objective cough frequency and quality of life among patients using the Leicester Cough Questionnaire, which 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.
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Postoperative 12 month follow up at outpatient clinic
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Serum TRPA1, TRPV1, bradykinin, PGE2 measurements
Lasso di tempo: Preoperative day
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Measurement of TRPA1 (ng/mL), TRPV1 (ng/mL), bradykinin (pg/mL), PGE2 (pg/mL) (released from C-fibers) via enzyme-linked immunosorbent assay (ELISA) test to quantitatively measure the injures of the vagus nerve during the mediastinal lymph node dissection.
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Preoperative day
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Serum TRPA1, TRPV1, bradykinin, PGE2 measurements
Lasso di tempo: Postoperative 1 day
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Measurement of TRPA1 (ng/mL), TRPV1 (ng/mL), bradykinin (pg/mL), PGE2 (pg/mL) (released from C-fibers) via enzyme-linked immunosorbent assay (ELISA) test to quantitatively measure the injures of the vagus nerve during the mediastinal lymph node dissection.
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Postoperative 1 day
|
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Serum TRPA1, TRPV1, bradykinin, PGE2 measurements
Lasso di tempo: Postoperative 2 month follow up at outpatient clinic
|
Measurement of TRPA1 (ng/mL), TRPV1 (ng/mL), bradykinin (pg/mL), PGE2 (pg/mL) (released from C-fibers) via enzyme-linked immunosorbent assay (ELISA) test to quantitatively measure the injures of the vagus nerve during the mediastinal lymph node dissection.
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Postoperative 2 month follow up at outpatient clinic
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Pulmonary function test
Lasso di tempo: Preoperative day
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Routine PFT (FEV1%, FEV1/FVC%) check to evaluate the effects of vagus nerve preservation in pulmonary function
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Preoperative day
|
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Pulmonary function test
Lasso di tempo: Postoperative 1 month follow up at outpatient clinic
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Routine PFT (FEV1%, FEV1/FVC%) check to evaluate the effects of vagus nerve preservation in pulmonary function
|
Postoperative 1 month follow up at outpatient clinic
|
|
Pulmonary function test
Lasso di tempo: Postoperative 2 month follow up at outpatient clinic
|
Routine PFT (FEV1%, FEV1/FVC%) check to evaluate the effects of vagus nerve preservation in pulmonary function
|
Postoperative 2 month follow up at outpatient clinic
|
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Pulmonary function test
Lasso di tempo: Postoperative 6 month follow up at outpatient clinic
|
Routine PFT (FEV1%, FEV1/FVC%) check to evaluate the effects of vagus nerve preservation in pulmonary function
|
Postoperative 6 month follow up at outpatient clinic
|
|
Pulmonary function test
Lasso di tempo: Postoperative 12 month follow up at outpatient clinic
|
Routine PFT (FEV1%, FEV1/FVC%) check to evaluate the effects of vagus nerve preservation in pulmonary function
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Postoperative 12 month follow up at outpatient clinic
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Incidence of postoperative pulmonary complications, hospital stay and readmission, ICU care
Lasso di tempo: from admission for operation to until the date of first documented postoperative complication or readmission, whichever came first), assessed up to 30 days
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from admission for operation to until the date of first documented postoperative complication or readmission, whichever came first), assessed up to 30 days
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Histopathologic review of the total number of mediastinal lymph node dissected
Lasso di tempo: through study completion, an average of 1 year
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Total number of dissected mediastinal lymph nodes and metastatic lymph nodes will be analyzed.
Patient's preoperative clinical N stage and pathologic N stage will be compared; if pathologic N stage is higher than that of the clinical N stage, it will be considered as nodal upstaging.
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through study completion, an average of 1 year
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Investigatori
- Direttore dello studio: Kwhanmien Kim, MD. PhD, Department of Thoracic and Cardiovascular Surgery, Seoul National University Bundang Hospital
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- Zhu YF, Wu SB, Zhou MQ, Xie MR, Xiong R, Xu SB, Xu GW. Increased expression of TRPV1 in patients with acute or chronic cough after lung cancer surgery. Thorac Cancer. 2019 Apr;10(4):988-991. doi: 10.1111/1759-7714.13042. Epub 2019 Mar 18.
- 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.
- Kwon 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.
- Al-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.
- Chen 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.
- Huang 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.
- Lin 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.
- Liu 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.
- 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.
- 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.
- Spinou A, Birring SS. An update on measurement and monitoring of cough: what are the important study endpoints? J Thorac Dis. 2014 Oct;6(Suppl 7):S728-34. doi: 10.3978/j.issn.2072-1439.2014.10.08.
- Watanabe A, Nakazawa J, Miyajima M, Harada R, Nakashima S, Mawatari T, Higami T. Thoracoscopic mediastinal lymph node dissection for lung cancer. Semin Thorac Cardiovasc Surg. 2012 Spring;24(1):68-73. doi: 10.1053/j.semtcvs.2012.03.002.
- Yang P, Cheville AL, Wampfler JA, Garces YI, Jatoi A, Clark MM, Cassivi SD, Midthun DE, Marks RS, Aubry MC, Okuno SH, Williams BA, Nichols FC, Trastek VF, Sugimura H, Sarna L, Allen MS, Deschamps C, Sloan JA. Quality of life and symptom burden among long-term lung cancer survivors. J Thorac Oncol. 2012 Jan;7(1):64-70. doi: 10.1097/JTO.0b013e3182397b3e.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
1 luglio 2021
Completamento primario (Anticipato)
30 giugno 2023
Completamento dello studio (Anticipato)
30 giugno 2023
Date di iscrizione allo studio
Primo inviato
23 maggio 2021
Primo inviato che soddisfa i criteri di controllo qualità
6 giugno 2021
Primo Inserito (Effettivo)
11 giugno 2021
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
26 ottobre 2022
Ultimo aggiornamento inviato che soddisfa i criteri QC
24 ottobre 2022
Ultimo verificato
1 ottobre 2022
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Malattie del sistema nervoso
- Malattie delle vie respiratorie
- Neoplasie
- Disturbi respiratori
- Malattie polmonari
- Neoplasie per sede
- Ferite e lesioni
- Neoplasie delle vie respiratorie
- Neoplasie toraciche
- Trauma craniocerebrale
- Trauma, sistema nervoso
- Segni e sintomi, respiratori
- Malattie dei nervi cranici
- Malattie del nervo vago
- Lesioni del nervo cranico
- Neoplasie polmonari
- Tosse
- Lesioni del nervo vago
Altri numeri di identificazione dello studio
- B-2007-625-007
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .