Surgical Compared to Bronchoscopic Lung Volume Reduction in Patients With Severe Emphysema (SINCERE)
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ClinicalTrials.gov Identifier: NCT04537182 |
Recruitment Status :
Recruiting
First Posted : September 3, 2020
Last Update Posted : May 27, 2022
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Condition or disease | Intervention/treatment | Phase |
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Emphysema | Procedure: Lung volume reduction surgery Procedure: Bronchoscopic lung volume reduction with valves | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 120 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | International, multi-center, open label, morphology- and site-stratified, 1:1 randomized, actively controlled |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Surgical Compared to Bronchoscopic Lung Volume Reduction in Patients With Severe Emphysema: an International Multi-center Randomized Controlled Trial |
Actual Study Start Date : | September 1, 2020 |
Estimated Primary Completion Date : | November 2023 |
Estimated Study Completion Date : | November 2024 |
Arm | Intervention/treatment |
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Experimental: LVRS treatment group
A bilateral lung volume reduction surgery (LVRS) by video-assisted thoracoscopic surgery (VATS) is performed under general anesthesia with double lumen endobronchial intubation. Unilateral treatment is accepted in cases with severe adhesions or intraoperative instability making a bilateral procedure unsafe.
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Procedure: Lung volume reduction surgery
Lung volume reduction by surgery
Other Name: LVRS |
Active Comparator: BLVR study group
Unilateral bronchoscopic lung volume reduction with endobronchial valves (EBV) is performed using a flexible bronchoscope under general anesthesia and under full attendance of an anesthesiologist. Valves are placed unilaterally in segmental or subsegmental bronchi in the target lobe with the goal of complete atelectasis.
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Procedure: Bronchoscopic lung volume reduction with valves
Lung volume reduction with endobronchial valves.
Other Name: BLVR |
- Change from baseline value in FEV1 (ml) [ Time Frame: 6 months after intervention ]Percent change in FEV1
- Change from baseline value in FEV1 [ Time Frame: 3 and 12 months after intervention ]Percent change in forced expiratory volume (FEV1)
- Change from baseline value in RV [ Time Frame: 3, 6 and 12 months after intervention ]Percent change in residual volume (RV)
- Change from baseline value in TLC [ Time Frame: 3, 6 and 12 months after intervention ]Percent change in total lung capacity (TLC)
- Change from baseline value in RV/TLC [ Time Frame: 3, 6 and 12 months after intervention ]Percent change in RV-to-TLC ratio
- Change from baseline value in DLCO [ Time Frame: 3, 6 and 12 months after intervention ]Percent change in diffusion capacity (DLCO)
- Change from baseline value in 6-minute walking distance [ Time Frame: 3, 6 and 12 months after intervention ]Distance that can be walked within 6 minutes
- Change from baseline value in mMRC dyspnea score [ Time Frame: 3, 6 and 12 months after intervention ]Degree of disability that breathlessness poses on day-to-day activities on a scale from 0 to 4
- Change from baseline in quality of life (SGRQ, EQ-5D-5L) [ Time Frame: 3, 6 and 12 months after intervention ]St. George's Respiratory Questionnaire to assess quality of life
- Change from baseline regarding pain (PDI score) [ Time Frame: 3, 6 and 12 months after intervention ]Pain Disability Index score
- Change from baseline regarding pain (VAS) [ Time Frame: 3, 6 and 12 months after intervention ]Pain assessment with visual analog scale (VAS)
- Incidence of (serious) adverse events / re-interventions [ Time Frame: 3, 6 and 12 months after intervention ]Number and degree of adverse events after intervention
- 30-days mortality [ Time Frame: 1 month ]Number of deaths (all causes) 1 month after intervention
- 90-days mortality [ Time Frame: 3 months ]Number of deaths (all causes) 3 months after intervention
- Overall survival rate [ Time Frame: 12 months ]Percentage of patients alive 1 year after intervention

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Ages Eligible for Study: | 30 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients suffering from emphysema (all morphologies) potentially qualifying for both study procedures, LVRS or BLVR (perfusion scintigraphy within < 6 month of screening, CT scan within < 3 months of screening)
- • Patients with bilateral emphysema not exceeding perfusion and/or volume side differences of 70%:30% and therefore allowing a primary bilateral LVRS (borderline perfusion results regarding side dominance (+/- 5%) are accepted as long as CT morphology and volume-based perfusion morphology are suitable for bilateral LVRS)
- 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:
- Post-bronchodilator 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 ≥ 450m
- 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
- Any disease or condition that interferes with completion of initial or follow-up assessment
- Currently listed for lung transplantation
- Daily dose of prednisone ≥ 10mg
- Current enrollment in another clinical trial studying an experimental treatment.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04537182
Contact: Isabelle Opitz, Prof. MD | +41 44 255 11 11 | isabelle.schmitt-opitz@usz.ch | |
Contact: Nadine Bosbach, MSc | +41 44 255 92 30 | nadine.bosbach@usz.ch |
Belgium | |
University Hospital Leuven | Recruiting |
Leuven, Belgium, 3000 | |
Contact: Laurens Ceulemans, Prof MD laurens.ceulemans@uzleuven.be | |
Switzerland | |
Kantonsspital Aarau | Recruiting |
Aarau, Aargau, Switzerland, 5001 | |
Contact: Franco Gambazzi, PD MD franco.gambazzi@ksa.ch | |
Lausanne University Hospital (CHUV) | Recruiting |
Lausanne, Vaud, Switzerland, 1011 | |
Contact: Thorsten Krueger, Prof MD thorsten.krueger@chuv.ch | |
University Hospital Zurich, Division of Thoracic Surgery | Recruiting |
Zurich, ZH, Switzerland, 8091 | |
Contact: Isabelle Opitz, Prof MD +41 44 255 11 11 isabelle.schmitt-opitz@usz.ch |
Principal Investigator: | Isabelle Opitz, Prof. MD | University of Zurich |
Responsible Party: | Isabelle Opitz, Professor, MD, Prof. MD, University of Zurich |
ClinicalTrials.gov Identifier: | NCT04537182 |
Other Study ID Numbers: |
SINCERE |
First Posted: | September 3, 2020 Key Record Dates |
Last Update Posted: | May 27, 2022 |
Last Verified: | May 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
LVRS BLVR endobronchial valves heterogeneous empyhsema non-heterogeneous emphysema |
Pulmonary Emphysema Emphysema Pathologic Processes Pulmonary Disease, Chronic Obstructive |
Lung Diseases, Obstructive Lung Diseases Respiratory Tract Diseases |