Surgical Compared to Bronchoscopic Lung Volume Reduction in Patients With Severe Emphysema

Официальное название

Surgical Compared to Bronchoscopic Lung Volume Reduction in Patients With Severe Emphysema: an International Multi-center Randomized Controlled Trial

Обзор

The investigators plan to perform a randomized controlled trial that compares bilateral lung volume reduction surgery (LVRS) with bronchoscopic lung volume reduction (BLVR) using endobronchial valves in terms of efficacy and patient safety.

Подробное описание

Advanced lung emphysema has a considerable impact on quality of life in patients with chronic obstructive pulmonary disease. There are positive reports of surgical as well as bronchoscopic volume reduction in selected patients, but data comparing LVRS and BLVR is unfortunately lacking to date. The investigators therefore anticipate that their study will make an important contribution to the worldwide efforts in better understanding selection and management of surgical and bronchoscopic treatment of emphysema patients and that it will be of high public interest.

Вмешательства

• Процедура Lung volume reduction surgery
  Lung volume reduction by surgery
• Процедура Bronchoscopic lung volume reduction with valves
  Lung volume reduction with endobronchial valves.

Первичные конечные точки

• Change from baseline value in FEV1 (ml) [Срок оценки: 6 months after intervention]

Вторичные конечные точки (12)

• Change from baseline value in FEV1 [Срок оценки: 3 and 12 months after intervention]
• Change from baseline value in RV [Срок оценки: 3, 6 and 12 months after intervention]
• Change from baseline value in TLC [Срок оценки: 3, 6 and 12 months after intervention]
• Change from baseline value in RV/TLC [Срок оценки: 3, 6 and 12 months after intervention]
• Change from baseline value in DLCO [Срок оценки: 3, 6 and 12 months after intervention]
• Change from baseline value in 6-minute walking distance [Срок оценки: 3, 6 and 12 months after intervention]
• Change from baseline value in mMRC dyspnea score [Срок оценки: 3, 6 and 12 months after intervention]
• Change from baseline in quality of life (SGRQ, EQ-5D-5L) [Срок оценки: 3, 6 and 12 months after intervention]
• Change from baseline regarding pain (PDI score) [Срок оценки: 3, 6 and 12 months after intervention]
• Change from baseline regarding pain (VAS) [Срок оценки: 3, 6 and 12 months after intervention]
• Incidence of (serious) adverse events / re-interventions [Срок оценки: 3, 6 and 12 months after intervention]
• 30-days mortality [Срок оценки: 1 month]

Критерии участия

Критерии включения

• Patients suffering from emphysema (all morphologies, uni- or bilateral distribution) potentially qualifying for both study procedures, LVRS or BLVR (if possible, perfusion scintigraphy within < 6 month of screening, CT scan within < 4 months of screening)
• Age ≥ 30 and ≤ 80 years
• Body Mass Index (BMI) ≥ 16, but ≤ 35 kg/m2
• Non-smoking for 3 months prior to screening interview
• Patient is able to understand and willing to sign a written informed consent document.

Критерии исключения

• FEV1 more than 50% predicted
• TLC less than 100 % predicted, RV less than 175% predicted, RV/TLC less than 58% predicted, and DLCO ≤ 20% predicted in homogeneous emphysema and DLCO ≤ 15% in heterogeneous emphysema, respectively
• PaO2 ≤ 6.0 kPa (45mm Hg) at ambient air (only applicable for homogeneous morphology!)
• PaCO2 ≥ 6.6 kPa (50 mmHg) at ambient air (only applicable for homogeneous morphology!)
• Patients with incomplete interlobar fissures as revealed by quantitative computed tomography analysis with StratX® (fissure completeness ≤ 80%)
• Patients with collateral ventilation as evidenced by bronchoscopic Chartis® measurement (only performed if fissure completeness according to StratX® is < 95%)
• 6-minute walking distance ≥ 470m
• More than two COPD exacerbation episodes requiring hospitalization in the last year
• More than two instances of pneumonia episodes in the last year
• Unplanned weight loss ≥ 10% within 90 days prior to enrollment
• Pulmonary hypertension as evidenced by Delta Psyst RV-RA > 35 mmHg on recent echocardiography (within 3 months prior to screening) and confirmed by RHC (mPAP ≥ 35 mmHg) and signs of moderate to severe RV dysfunction.
• Evidence of left ventricular ejection fraction (LVEF) less than 45% on recent echocardiography (within 3 months prior to screening)
• History of exercise-related syncope
• Myocardial infarction or congestive heart failure within 6 months of screening
• Clinically significant arrhythmias that might put the patient at risk in regard to the interventions
• Prior LVR (any method), bullectomy, or lobectomy
• Clinically significant bronchiectasis with expectoration of ≥ 2 tablespoons/day.
• Pulmonary nodule requiring surgery
• Unable to safely discontinue anticoagulants or dual antiplatelet therapy for 7 days
• Patients with a life expectancy of less than one year

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Швейцария · 3 центра

• Kantonsspital Aarau — Aarau
• Lausanne University Hospital (CHUV) — Lausanne
• University Hospital Zurich, Division of Thoracic Surgery — Zurich

Австрия · 1 центр

• Universitätsklinik für Thoraxchirurgie, Medical University of Vienna — Vienna

Бельгия · 1 центр

• University Hospital Leuven — Leuven

Дания · 1 центр

• Rigshospitalet, University of Copenhagen — Copenhagen

Идентификаторы

NCT: NCT04537182 · SINCERE

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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