Vagus Nerve Preservation and Chronic Cough in Non-small Cell Lung Cancer Surgery
24 października 2022 zaktualizowane przez: 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.
Przegląd badań
Status
Rekrutacyjny
Warunki
Typ studiów
Interwencyjne
Zapisy (Oczekiwany)
214
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Kontakt w sprawie studiów
- Nazwa: Kwhanmien Kim, MD. PhD
- Numer telefonu: +82-31-787-7130
- E-mail: kmkim0070@snubh.org
Lokalizacje studiów
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Bundang
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Seongnam-si, Bundang, Republika Korei, 13620
- Rekrutacyjny
- Seoul National University
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Kontakt:
- Beatrice C Shih, MD
- Numer telefonu: 821091094533
- E-mail: 82430@snubh.org
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Główny śledczy:
- Kwhanmien Kim, MD.PhD.
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
18 lat do 80 lat (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Opis
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
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: 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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Eksperymentalny: 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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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Qualitative measurement of postoperative cough
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: Postoperative 1 month follow up at outpatient clinic
|
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
Ramy czasowe: Postoperative 2 month follow up at outpatient clinic
|
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
Ramy czasowe: Postoperative 6 month follow up at outpatient clinic
|
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
Ramy czasowe: Postoperative 12 month follow up at outpatient clinic
|
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
Ramy czasowe: 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.
|
Preoperative day
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Quantitative measurement of postoperative cough
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: Postoperative 6 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.
|
Postoperative 6 month follow up at outpatient clinic
|
|
Quantitative measurement of postoperative cough
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Serum TRPA1, TRPV1, bradykinin, PGE2 measurements
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
|
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Pulmonary function test
Ramy czasowe: 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
|
|
Pulmonary function test
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Śledczy
- Dyrektor Studium: Kwhanmien Kim, MD. PhD, Department of Thoracic and Cardiovascular Surgery, Seoul National University Bundang Hospital
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Publikacje ogólne
- 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.
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
1 lipca 2021
Zakończenie podstawowe (Oczekiwany)
30 czerwca 2023
Ukończenie studiów (Oczekiwany)
30 czerwca 2023
Daty rejestracji na studia
Pierwszy przesłany
23 maja 2021
Pierwszy przesłany, który spełnia kryteria kontroli jakości
6 czerwca 2021
Pierwszy wysłany (Rzeczywisty)
11 czerwca 2021
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
26 października 2022
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
24 października 2022
Ostatnia weryfikacja
1 października 2022
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
- Choroby Układu Nerwowego
- Choroby Układu Oddechowego
- Nowotwory
- Zaburzenia oddychania
- Choroby płuc
- Nowotwory według lokalizacji
- Rany i urazy
- Nowotwory Układu Oddechowego
- Nowotwory klatki piersiowej
- Uraz czaszkowo-mózgowy
- Uraz, układ nerwowy
- Oznaki i objawy, układ oddechowy
- Choroby nerwów czaszkowych
- Choroby nerwu błędnego
- Urazy nerwu czaszkowego
- Nowotwory płuc
- Kaszel
- Urazy nerwu błędnego
Inne numery identyfikacyjne badania
- B-2007-625-007
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIE
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .