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

11 ottobre 2019 aggiornato da: 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.

Panoramica dello studio

Stato

Sconosciuto

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Anticipato)

120

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.

Luoghi di studio

  • Cina
    • Shanghai
      • Shanghai, Shanghai, Cina, 200000
        • Reclutamento
        • Yongxin Zhou
        • Contatto:
        • Contatto:

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:

  • (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.

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
Sperimentale: Preservation of pulmonary vagus nerve
Preservation of pulmonary branches of vagus nerve in minimally invasive surgery for lung cancer
Altro: In minimally invasive surgery，Vagus nerve preservation
In minimally invasive surgery for lung cancer, the experimental group retained the pulmonary branches of vagus nerve
Sperimentale: No pulmonary vagus nerve preservation
In minimally invasive surgery for lung cancer, the pulmonary branches of vagus nerve were severed
Altro: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
cough after pulmonary resection
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Operation time;
Lasso di tempo: 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;
Lasso di tempo: 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;
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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;
Lasso di tempo: 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;
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Shanghai Tongji Hospital, Tongji University School of Medicine

Investigatori

  • Direttore dello studio: Yongxin zhou, Doctor, Tongji Hospital Affiliated to Tongji University

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

Collegamenti utili

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 gennaio 2019

Completamento primario (Anticipato)

30 gennaio 2021

Completamento dello studio (Anticipato)

31 gennaio 2022

Date di iscrizione allo studio

Primo inviato

5 ottobre 2019

Primo inviato che soddisfa i criteri di controllo qualità

11 ottobre 2019

Primo Inserito (Effettivo)

14 ottobre 2019

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

14 ottobre 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

11 ottobre 2019

Ultimo verificato

1 ottobre 2019

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2019-LCYJ-006

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

prodotto fabbricato ed esportato dagli 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 .

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