BENTO - Bronchoscopic Lung Volume Reduction in Severe Emphysema Using Thermoablation

Официальное название

Bronchoscopic Lung Volume Reduction in Severe Emphysema Using Thermoablation

Обзор

Prospective, 2-arm, randomised (2:1), multicentre, open-label clinical trial in patients with severe emphysema. The intervention arm will be treated with Bronchoscopic lung volume reduction in severe emphysema using thermoablation.The interventional treatment (bronchoscopic lung volume reduction) is compared with the usual conservative standard therapy (GOLD guidelines).

Подробное описание

Currently, there is less data on the use of bronchoscopic thermoablation (BTVA) for the treatment of patients with emphysema. However, the current studies suggest with a high degree of certainty that bronchoscopic lung volume reduction for severe emphysema using thermoablation has the potential to be a necessary treatment alternative. The trial study should therefore contribute to proving the benefit of this procedure as an effective and safe treatment option in order to guarantee emphysema patients sufficient, appropriate and economical care, taking into account evidence-based medical knowledge.

Вмешательства

• Устройство InterVapor®-System
  The InterVapor System uses heated water vapor to ablate the airways and parenchyma within targeted regions of the lung. Lung remodeling occurs after an initial localized inflammatory response and a subsequent healing and repair. The remodeling of the tissue results in reductions in tissue and air volume in the targeted regions of the lung. The remodeled lung tissue does not re-inflate as a result of collateral ventilation. The lung volume reduction of diseased hyper-inflated lung segments after

Первичные конечные точки

• Change in patient-reported disease-specific quality of life [Срок оценки: 9 months]

Вторичные конечные точки (8)

• Vital status [Срок оценки: 3, 9 and 12 months]
• Change in FEV 1 [Срок оценки: 3, 9 and 12 months]
• Change in RV [Срок оценки: 3, 9 and 12 months]
• Change in patient-reported, disease-specific quality of life [Срок оценки: 3, 9 and 12 months]
• Serious Adverse Events [Срок оценки: 3, 9 and 12 months]
• 6-minute walk test (6MWT) [Срок оценки: 3, 9 and 12 months]
• Severe excacerbations [Срок оценки: 3, 9 and 12 months]
• Mortality [Срок оценки: 3, 9 and 12 months]

Критерии участия

Критерии включения

• Age: ≥ 40 years and ≤ 75 years
• Written informed consent obtained from the patient
• Severe emphysema with indication for BTVA:
• bilateral heterogeneous emphysema of the upper lobes in GOLD stage 3/4 and
• evidence of severe emphysema in high-resolution computed tomography (not older than 6 months prior to inclusion) and
• functional evidence of severe pulmonary hyperinflation and
• FEV1 post lysis between 20% and < 45% (calculated) and
• Total lung capacity (TLC) ≥ 100% (calculated) and
• Residual volume (RV) > 175% (calculated) and
• arterial blood gas values of: PaCO2 ≤ 50 mmHg; PaO2 > 50 mmHg on room air and
• marked dyspnoea with a score ≥ 2 on the Medical Research Council modified scale (mMRC) and
• 6-minute walk test > 140 metres
• Patient-specific, pre-interventional exhaustion of conservative treatment options
• optimised medical therapy (according to the GOLD guidelines) and
• Non-smoker for 6 months prior to inclusion
• Evidence of completed pulmonary and geriatric rehabilitation in the last 4 years
• ≥ 6 weeks outpatient or
• ≥ 3 weeks inpatient or
• Individual Participation in regular physical activities that go beyond the activities of daily living (e.g. a walking programme)
• According to the investigator's assessment mentally and physically able to participate in the study procedures and visits
• Indication within the framework of an interdisciplinary case conference with specialists in pneumology, radiology and thoracic surgery in accordance with §3 of the guideline on quality assurance measures in accordance with § 136 Paragraph 1 Sentence 1 Number 2 SGB V for inpatient care with bronchoscopic lung volume reduction procedures for severe emphysema (QS-RL BLVR).

Критерии исключения

• Any condition that would interfere with the conduct of the clinical trial follow-up or bronchoscopy or affect the outcome of the clinical trial
• DLCO < 20% (calculated)
• Body mass index (BMI) < 18 kg/m2 or > 32 kg/m2
• Pulmonary hypertension
• Peak systolic PAP > 45 mmHg or mean PAP > 25 mmHg
• Right heart catheter measurements are considered authoritative over echocardiogram measurements
• Clinically significant bronchiectasis
• Pneumothorax or pleural effusions within the last 6 months
• Heart and/or lung transplantation, surgical lung volume reduction (LVRS), bullectomy, lobectomy or pneumonectomy, pleurodesis or any surgery in the target lobes (upper lobes).
• Recent respiratory infection or COPD exacerbation in the last 6 weeks
• Unstable COPD (any of the following conditions):
• >3 COPD-related hospitalisations requiring antibiotics in the last 12 months
• COPD-related hospital stay in the last 3 months
• daily use of systemic steroids, > 5 mg prednisolone
• Single large bulla (defined as > 1/3 of the volume of the lobe) in the upper lobe or paraseptal emphysema distribution in the lobe being treated
• Coagulopathy or current use of anticoagulants
• Patients with current endobronchial valves or with valves explanted less than 6 months ago in the target lobe in a segment to be treated with InterVapor®.
• Patients with implanted, endobronchial coils (coils)
• Patients with previous endobronchial polymer/adhesive treatment
• Patients with immune system disorders or concomitant diseases that necessitate the use of immunosuppressants of clinical relevance
• History of any of the following conditions:
• Myocardial infarction or acute coronary syndrome in the previous year
• Hospitalisation for left heart failure in the last year
• clinically leading asthma disease or alpha-1-antitrypsin deficiency
• Known sensitivity to medications required to perform bronchoscopy
• Life expectancy < 12 months
• Newly prescribed morphine derivatives within the last 4 weeks
• Pregnancy at the time of inclusion

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

Профилактика

Центры проведения

Германия · 12 центров

• Charité Campus Benjamin Franklin — Berlin
• Gemeinschaftskrankenhaus Havelhöhe gGmbH Klinik für Anthroposophische Medizin — Berlin
• Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik II — Bonn
• Pneumologische Universitätsklinik Ruhrlandklinik — Essen
• Universitätsklinikum Halle (Saale) — Halle
• Thoraxklinik University of Heidelberg — Heidelberg
• Lungenklinik Hemer — Hemer
• Lungenfachklinik Immenhausen — Immenhausen
• … и ещё 4 центра

Публикации

• Kontogianni K, Darwiche K, Huebner RH, Hassinger F, Riemer T, Herth FJ, Brock J. Design of the multicentre randomised controlled BENTO trial to demonstrate patient-relevant benefit of bronchoscopic lung volume reduction using thermal vapour ablation in the German healthcare system for patients with upper lobe emphysema: a study protocol. BMJ Open. 2024 May 28;14(5):e080518. doi: 10.1136/bmjopen-20 PMID 38806430

Идентификаторы

NCT: NCT05717192 · MDR-0002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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