Clinical Evaluation of Vagal Nerve Preservation in Minimally Invasive Surgery for Early Lung Cancer (CEVNPIMISELC)
11 octobre 2019 mis à jour par: Yongxin Zhou, Shanghai Tongji Hospital, Tongji University School of Medicine
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.
Aperçu de l'étude
Statut
Inconnue
Les conditions
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Anticipé)
120
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Wenli Wang, Master's degree
- Numéro de téléphone: 86021661110 13761295864
- E-mail: Anderson840913@163.com
Sauvegarde des contacts de l'étude
- Nom: Yongxin zhou, Doctor
- Numéro de téléphone: 13681666828
- E-mail: zhou6302@tongji.edu.cn
Lieux d'étude
-
-
Shanghai
-
Shanghai, Shanghai, Chine, 200000
- Recrutement
- Yongxin Zhou
-
Contact:
- Wenli Wang, Master
- Numéro de téléphone: 13761295864
- E-mail: Anderson840913@163.com
-
Contact:
- Shaorui Gu, scholor
- Numéro de téléphone: 18351977377
- E-mail: 870005908@qq.com
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 80 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- (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.
Exclusion Criteria:
- (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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Preservation of pulmonary vagus nerve
Preservation of pulmonary branches of vagus nerve in minimally invasive surgery for lung cancer
|
In minimally invasive surgery for lung cancer, the experimental group retained the pulmonary branches of vagus nerve
|
|
Expérimental: No pulmonary vagus nerve preservation
In minimally invasive surgery for lung cancer, the pulmonary branches of vagus nerve were severed
|
In minimally invasive surgery for lung cancer, the control group did not retain the vagus nerve.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
cough after pulmonary resection
Délai: 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
|
From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
|
|
pulmonary infection
Délai: 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:
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. |
From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
|
|
Atelectasis
Délai: 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%.
|
From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
|
|
hydrothorax
Délai: 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.
|
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
Délai: From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
|
Tracheal intubation; Ventilator; ICU
|
From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Operation time;
Délai: From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
|
Operation time;
|
From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
|
|
Intraoperative bleeding volume;
Délai: From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
|
Intraoperative bleeding volume;
|
From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
|
|
Postoperative drainage volume;
Délai: From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
|
Postoperative drainage volume;
|
From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
|
|
Postoperative mortality
Délai: From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
|
Postoperative mortality
|
From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
|
|
Postoperative cardiovascular complications
Délai: From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
|
Postoperative cardiovascular complications
|
From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
|
|
Re-admission ICU rate;
Délai: From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
|
Re-admission ICU rate;
|
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;
Délai: 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;
|
From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
|
|
Hospitalization days
Délai: From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
|
Hospitalization days
|
From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
|
|
Hospitalization expenses
Délai: From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
|
Hospitalization expenses
|
From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Les enquêteurs
- Directeur d'études: Yongxin zhou, Doctor, Tongji hospital affiliated to tongji university
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
- 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.
- 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.
- Weijs 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 janvier 2019
Achèvement primaire (Anticipé)
30 janvier 2021
Achèvement de l'étude (Anticipé)
31 janvier 2022
Dates d'inscription aux études
Première soumission
5 octobre 2019
Première soumission répondant aux critères de contrôle qualité
11 octobre 2019
Première publication (Réel)
14 octobre 2019
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
14 octobre 2019
Dernière mise à jour soumise répondant aux critères de contrôle qualité
11 octobre 2019
Dernière vérification
1 octobre 2019
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2019-LCYJ-006
Plan pour les données individuelles des participants (IPD)
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Non
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
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produit fabriqué et exporté des États-Unis.
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