Bronchoscopic Thermal Saline Ablation (BTSA) of Emphysematous Lung. A New Emphysema Therapy (BTSA)

Lung Volume Reduction in COPD Patients With an Inhomogeneous Severe Emphysema Located in the Upper Lobes, by Injecting Warm Saline Through the Bronchoscope Channel

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;

Study Overview

• Status: Unknown
• Conditions: Emphysema
• Intervention / Treatment: Procedure: Endoscopic lung volume reduction

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: David Stav, MD; Phone Number: 972- 89779024; Email: dstav@asaf.health.gov.il
• Study Contact Backup: Name: Isaac Shpirer, MD; Phone Number: 972- 89779024

Study Locations

• Israel
  • Beer Yaakov, Israel, 70300
    • Recruiting
    • Assaf Harofeh Medical Center
    • Principal Investigator: David Stav, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Endoscopic lung volume reduction; After usual sedation, bronchoscope is introduce to the lung and palced in segmental wedge position then hot salineis instilled. Same procedure to others affected segments.	Procedure: Endoscopic lung volume reduction; Prior the procedure patients undergo - high resolution chest CT , extensive phisiological assessment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulmonary function improvemnt	Clinical - COPD assessment test (CAT ) + lung volumes + diffusion capaciry and 6MWD .	6 months

Collaborators and Investigators

• Sponsor: Assaf-Harofeh Medical Center
• Investigators: Principal Investigator: David stav, MD, Assaf-Harofeh Medical Center

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Anticipated): June 1, 2014
• Study Completion (Anticipated): December 1, 2014

Study Registration Dates

• First Submitted: July 16, 2013
• First Submitted That Met QC Criteria: August 8, 2013
• First Posted (Estimate): August 12, 2013

Study Record Updates

• Last Update Posted (Estimate): August 12, 2013
• Last Update Submitted That Met QC Criteria: August 8, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: COPD; Emphysema; Bronchoscopic LVR; Hot injury
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Pulmonary Emphysema; Emphysema
• Other Study ID Numbers: 195/12