Clinical trial NCT01920321: Bronchoscopic Thermal Saline Ablation (BTSA) of Emphysematous Lung. A New Emphysema Therapy
Official title: Lung Volume Reduction in COPD Patients With an Inhomogeneous Severe Emphysema Located in the Upper Lobes, by Injecting Warm Saline Through the Bronchoscope Channel
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Emphysema
Keywords: COPD
Bronchoscopic LVR
Emphysema
Hot injury
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2013-08-12
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Aim: To evaluate feasibility, safety and efficacy of relatively simple approach of bronchoscopic lung volume reduction (LVR) technology, independent of collateral ventilation.

Description: Patients with severe upper lobes heterogeneous emphysema, undergo unilateral bronchoscopic installation of saline thermal energy 50-55 ºC intending to induce an inflammatory airway and parenchymal injury and consequently fibrotic response resulting in LVR;

Detailed description: Inclusion criteria:

1. Age 40-75 unlimited sex. 20 subjects
2. chronic obstructive pulmonary disease (COPD), GOLD 3-4 (global obstructive lung disease).
3. CT scan of lung and included high resolution slices. Demonstrating emphysematous, bullotic changes in the upper lobes.
4. Pulmonary function tests results- total lung capacity(TLC)\>110%, residual volume(RV)\>150%, diffusion of lung CO(DLCO)\<80%,forced expiratory volume 1 second(FEV1):15-45%.
5. 6 minute walking distance (6MWD)\> 140 meters.

Exclusion criteria:

1. Active ischemic heart disease, significant arrhythmia. ejection fraction (EF) \<40%.
2. COPD that cause carbon bioxide(CO2) retention above 50 mm Hg and / or oxygen saturation at rest below 88%.
3. Pulmonary hypertension\> 45 mmHg, according to the Echo Test.
4. . Cancer treatment with chemotherapy / radiation or expected life expectancy of less than two years.5. Pregnancy.

Methods: . A. Patient preparation and sedation as in diagnostic bronchoscopy. Sedation will be based on midzoln + demerol. The patients will be treated prior the treatment with Inhalation with salbutamol ans ipratropium bromide. Flexible bronchoscope with outer diameter 5 mm is introduced to the targated upper lobe, and placed in wedged position. This is followed by installion of 0.9% natriu, chloride(NaCl) at a temperature of 55ºC exit temperature 50ºC) in portions of 40 ml to 200 ml (in bronchoalveolar lavage up to 300 ml is acceptable. The patient is placed in horizontal position, and continuous ECG blood pressure. Oxygen saturation are monitored. This monitoring will be continue at least 2 hours after treatment. A chest x-ray is followed and the patient remain in the department for overnight.

Tracking: Minimum of 6 months - Outpatient follow up include in addition to physical examination extended pulmonary function test and after 3-6 months. low radiation chest CT.

Eligibility criteria: Inclusion Criteria:

1. Age 40-75 unlimited sex. 20 subjects
2. COPD, GOLD 3-4 (global obstructive lung disease).
3. CT scan of lung and included high resolution slices. Demonstrating emphysematous, bullotic changes in the upper lobes.
4. Pulmonary function tests results- TLC\> 110%, RV\> 150%, DLCO \<80%,FEV1: 15-45%.
5. 6 minute walking distance \> 140 meters.

   -

Exclusion Criteria:

1. Active ischemic heart disease, significant arrhythmia. Ejection fraction (EF) \<40%.
2. Chronic lung disease that cause CO2 retention above 50 mm Hg and / or oxygen saturation at rest below 88%.
3. Pulmonary hypertension\> 45 mmHg, according to the Echo Test.
4. . Cancer treatment with chemotherapy / radiation or expected life expectancy of less than two years.
5. Pregnancy -

Primary outcomes:
measure: Pulmonary function improvemnt
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beer Yaakov
country: Israel
facility: Assaf Harofeh Medical Center
Study officials:
affiliation: Assaf-Harofeh Medical Center
name: david Stav, MD
role: PRINCIPAL_INVESTIGATOR
References: