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

Emphysema Clinical Trial

— SINCERE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04537182
• Other study ID #: SINCERE
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: March 2028

Study information

• Verified date: May 2024
• Source: University of Zurich
• Contact: Isabelle Opitz, Prof. MD
• Phone: +41 44 255 11 11
• Email: isabelle.schmitt-opitz[@]usz.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: March 2028
• Est. primary completion date: March 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Emphysema
• Pulmonary Emphysema

Intervention

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

Locations

Country	Name	City	State
Austria	Universitätsklinik für Thoraxchirurgie, Medical University of Vienna	Vienna
Belgium	University Hospital Leuven	Leuven
Denmark	Rigshospitalet, University of Copenhagen	Copenhagen
Switzerland	Kantonsspital Aarau	Aarau	Aargau
Switzerland	Lausanne University Hospital (CHUV)	Lausanne	Vaud
Switzerland	University Hospital Zurich, Division of Thoracic Surgery	Zurich	ZH

Sponsors (1)

Lead Sponsor	Collaborator
Isabelle Opitz, Professor, MD

Countries where clinical trial is conducted

Austria,  Belgium,  Denmark,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline value in FEV1 (ml)	Percent change in FEV1	6 months after intervention
Secondary	Change from baseline value in FEV1	Percent change in forced expiratory volume (FEV1)	3 and 12 months after intervention
Secondary	Change from baseline value in RV	Percent change in residual volume (RV)	3, 6 and 12 months after intervention
Secondary	Change from baseline value in TLC	Percent change in total lung capacity (TLC)	3, 6 and 12 months after intervention
Secondary	Change from baseline value in RV/TLC	Percent change in RV-to-TLC ratio	3, 6 and 12 months after intervention
Secondary	Change from baseline value in DLCO	Percent change in diffusion capacity (DLCO)	3, 6 and 12 months after intervention
Secondary	Change from baseline value in 6-minute walking distance	Distance that can be walked within 6 minutes	3, 6 and 12 months after intervention
Secondary	Change from baseline value in mMRC dyspnea score	Degree of disability that breathlessness poses on day-to-day activities on a scale from 0 to 4	3, 6 and 12 months after intervention
Secondary	Change from baseline in quality of life (SGRQ, EQ-5D-5L)	St. George's Respiratory Questionnaire to assess quality of life	3, 6 and 12 months after intervention
Secondary	Change from baseline regarding pain (PDI score)	Pain Disability Index score	3, 6 and 12 months after intervention
Secondary	Change from baseline regarding pain (VAS)	Pain assessment with visual analog scale (VAS)	3, 6 and 12 months after intervention
Secondary	Incidence of (serious) adverse events / re-interventions	Number and degree of adverse events after intervention	3, 6 and 12 months after intervention
Secondary	30-days mortality	Number of deaths (all causes) 1 month after intervention	1 month
Secondary	90-days mortality	Number of deaths (all causes) 3 months after intervention	3 months
Secondary	Overall survival rate	Percentage of patients alive 1 year after intervention	12 months