Clinical Evaluation of Vagal Nerve Preservation in Minimally Invasive Surgery for Early Lung Cancer (CEVNPIMISELC)
11. oktober 2019 oppdatert av: 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.
Studieoversikt
Status
Ukjent
Forhold
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Forventet)
120
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Shanghai
-
Shanghai, Shanghai, Kina, 200000
- Rekruttering
- Yongxin Zhou
-
Ta kontakt med:
- Wenli Wang, Master
- Telefonnummer: 13761295864
- E-post: Anderson840913@163.com
-
Ta kontakt med:
- Shaorui Gu, scholor
- Telefonnummer: 18351977377
- E-post: 870005908@qq.com
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 80 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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
|
|
Eksperimentell: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
cough after pulmonary resection
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Operation time;
Tidsramme: 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;
Tidsramme: 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;
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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;
Tidsramme: 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;
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Studieleder: Yongxin zhou, Doctor, Tongji Hospital Affiliated to Tongji University
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. januar 2019
Primær fullføring (Forventet)
30. januar 2021
Studiet fullført (Forventet)
31. januar 2022
Datoer for studieregistrering
Først innsendt
5. oktober 2019
Først innsendt som oppfylte QC-kriteriene
11. oktober 2019
Først lagt ut (Faktiske)
14. oktober 2019
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
14. oktober 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
11. oktober 2019
Sist bekreftet
1. oktober 2019
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2019-LCYJ-006
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Nei
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
produkt produsert i og eksportert fra USA
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .