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Clinical Evaluation of Vagal Nerve Preservation in Minimally Invasive Surgery for Early Lung Cancer (CEVNPIMISELC)

11. října 2019 aktualizováno: 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.

Přehled studie

Postavení

Neznámý

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Očekávaný)

120

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Čína
    • Shanghai
      • Shanghai, Shanghai, Čína, 200000
        • Nábor
        • Yongxin Zhou
        • Kontakt:
        • Kontakt:

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let až 80 let (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Preservation of pulmonary vagus nerve
Preservation of pulmonary branches of vagus nerve in minimally invasive surgery for lung cancer
Jiný: In minimally invasive surgery，Vagus nerve preservation
In minimally invasive surgery for lung cancer, the experimental group retained the pulmonary branches of vagus nerve
Experimentální: No pulmonary vagus nerve preservation
In minimally invasive surgery for lung cancer, the pulmonary branches of vagus nerve were severed
Jiný: In minimally invasive surgery，Vagus nerve is not preserved
In minimally invasive surgery for lung cancer, the control group did not retain the vagus nerve.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
cough after pulmonary resection
Časové okno: 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
Časové okno: 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:

  1. Fever occurred 72 hours after operation, and the body temperature increased again within T > 38 C or 72 hours.
  2. Leukocyte count increased (>12-15*109/L) or increased again after the leucocyte count returned to normal value, exceeding 10*109/L;
  3. Chest imaging showed consolidation of lung tissue or increasing patchy shadow;
  4. cough up purulent sputum or sputum culture positive;

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
Časové okno: 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
Časové okno: 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
Časové okno: 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.

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Operation time;
Časové okno: 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;
Časové okno: 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;
Časové okno: 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
Časové okno: 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
Časové okno: 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;
Časové okno: 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;
Časové okno: 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
Časové okno: 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
Časové okno: 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.

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Shanghai Tongji Hospital, Tongji University School of Medicine

Vyšetřovatelé

  • Ředitel studie: Yongxin zhou, Doctor, Tongji Hospital Affiliated to Tongji University

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Užitečné odkazy

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

1. ledna 2019

Primární dokončení (Očekávaný)

30. ledna 2021

Dokončení studie (Očekávaný)

31. ledna 2022

Termíny zápisu do studia

První předloženo

5. října 2019

První předloženo, které splnilo kritéria kontroly kvality

11. října 2019

První zveřejněno (Aktuální)

14. října 2019

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

14. října 2019

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

11. října 2019

Naposledy ověřeno

1. října 2019

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 2019-LCYJ-006

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

Ne

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

produkt vyrobený a vyvážený z USA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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