Safety and Efficacy of Endobronchial Valve for Bronchoscopic Lung Volume Reduction Surgery: a Prospective Pilot Study

Обзор

The goal of this pliot study al is to preliminarily evaluate the effectiveness and safety of transbronchial lung volume reduction surgery using the self-devloped endobronchial valves for chronic obstructive pulmonary disease patients with emphysema phenotype . The main questions it aims to answer are: Does self-devloped endobronchial valves improve the lung function、exercise capacity and symptons of participants? What surgery-related adverse events do participants have after transbronchial lung volume reduction surgery using the self-devloped endobronchial valves? Participants will: undergo transbronchial lung volume reduction surgery using the self-devloped endobronchial valves. receive follow-up before surgery (baseline) and 3 days, 4 weeks, 12weeks after surgery.

Вмешательства

• Процедура bronchoscopic lung volume reduction surgery using endobronchial valve
  The patients would undergo bronchoscopic lung volume reduction surgery using the self developed endobronchial valve.

Первичные конечные точки

• Percentage change in FEV1 relative to baseline [Срок оценки: 12 weeks after surgery]

Вторичные конечные точки (8)

• Percentage of subjects with FEV1 improvement ≥ 12% after bronchodilators [Срок оценки: 12 weeks after surgery]
• Percentage change in RV relative to baseline [Срок оценки: 12 weeks after surgery]
• Percentage change in TLC relative to baseline [Срок оценки: 12 weeks after surgery]
• Percentage change in DLCO relative to baseline [Срок оценки: 12 weeks after surgery]
• Percentage change in SGRQ score relative to baseline [Срок оценки: 12 weeks after surgery]
• Percentage change in mMRC grade relative to baseline [Срок оценки: 12 weeks after surgery]
• Percentage change in 6MWD relative to baseline [Срок оценки: 12 weeks after surgery]
• the incidence of surgical-related adverse events [Срок оценки: 12 weeks after surgery]

Критерии участия

Критерии включения

• 1\. Patients with chronic obstructive pulmonary disease based on GOLD diagnostic criteria;
• 2\. Age range from 40 to 85 years old (including 40 and 85 years old);
• 3\. BMI ≤ 35kg/m2;
• 4\. 15% ≤ FEV1% pred ≤ 45%;
• 5\. TLC>100% pred, RV>140% pred, and DLCO/red% ≥ 20%;
• 6\. 100m ≤ 6WMD ≤ 500m after rehabilitation training;
• 7\. Quit smoking for more than 4 months;
• 8\. The evaluation result of pulmonary bypass ventilation function is negative;
• 9\. Participants in this clinical trial requires the signing of an informed consent form by the individual or legal representative.

Критерии исключения

• 1\. Being pregnant or breastfeeding;
• 2\. PaCO2>50mmHg and/or PaO2<45mmHg;
• 3\. Obvious bronchiectasis or other infectious lung diseases;
• 4\. Hospitalization due to pulmonary infection or acute exacerbation of COPD within the past 12 months prior to baseline assessment twice or more times;
• 5\. Coagulation dysfunction, platelet count<60e+09/L;
• 6\. Myocardial infarction or congestive heart failure within the past 24 weeks;
• 7\. Previous lobectomy, LVRS or lung transplantation;
• 8\. Anticoagulant therapy that cannot be stopped before surgery;
• 9\. Uncontrolled pulmonary arterial hypertension (systolic pulmonary arterial pressure>45mmHg) or lungs diagnosed within the past 12 weeks Arterial hypertension;
• 10\. Left ventricular ejection fraction (LVEF) within the past 12 weeks is less than 45%;
• 11\. Pulmonary nodules that require intervention;
• 12\. Patients participating in other clinical trials;
• 13\. Individuals with other contraindications to bronchial operations;
• 14\. Other circumstances that the researcher deems unsuitable for participation in this clinical trial.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• China-Japan Friendship Hospital — Пекин

Идентификаторы

NCT: NCT06349174 · 2024-valve-1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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