EmphysemaSINCERENCT04537182
Surgical Compared to Bronchoscopic Lung Volume Reduction in Patients With Severe Emphysema
A study testing Lung volume reduction surgery and Bronchoscopic lung volume reduction with valves in people with Emphysema, run by Isabelle Opitz, Professor, MD at 6 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Emphysema
- What is being tested?
- Lung volume reduction surgery and Bronchoscopic lung volume reduction with valves
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 6 sitesin 4 countries
- Study dates
- 1 Sep 2020to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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%)
Show all 20Show fewer
- 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
Trial locations and contacts
6 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 4 countries
Switzerland3 sites, 3 recruiting
- Recruiting
Kantonsspital Aarau
Aarau, Canton of Aargau, 5001
Franco Gambazzi, PD MD, franco.gambazzi@ksa.ch
- Recruiting
Lausanne University Hospital (CHUV)
Lausanne, Canton of Vaud, 1011
Thorsten Krueger, Prof MD, thorsten.krueger@chuv.ch
- Recruiting
University Hospital Zurich, Division of Thoracic Surgery
Zurich, Canton of Zurich, 8091
Isabelle Opitz, Prof MD, +41 44 255 11 11, isabelle.schmitt-opitz@usz.ch
Austria1 site, 1 recruiting
- Recruiting
Universitätsklinik für Thoraxchirurgie, Medical University of Vienna
Vienna
Clemens Aigner, Prof. Dr., +43 (0)1 40400-56440, clemens.aigner@meduniwien.ac.at
Karl Kreissl, karl.kreissl@meduniwien.ac.at
Belgium1 site, 1 recruiting
- Recruiting
University Hospital Leuven
Leuven, 3000
Laurens Ceulemans, Prof MD, laurens.ceulemans@uzleuven.be
Denmark1 site, 1 recruiting
- Recruiting
Rigshospitalet, University of Copenhagen
Copenhagen, 2100
Rene Horsleben Petersen, Prof. PhD, +45 35450525, rene.horsleben.petersen@regionh.dk
Tina Refstrup Lund, tina.refstrup.lund.01@regionh.dk
About this study
Official title: Surgical Compared to Bronchoscopic Lung Volume Reduction in Patients With Severe Emphysema: an International Multi-center Randomized Controlled Trial
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.
Read the detailed 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.
- Conditions
- Emphysema
- Being tested
- Lung volume reduction surgery, Bronchoscopic lung volume reduction with valves
- Keywords
- LVRS, BLVR, endobronchial valves, heterogeneous empyhsema, non-heterogeneous emphysema
- Medical subject headings
- Emphysema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung volume reduction surgeryProcedure or surgery
Also called LVRS
Lung volume reduction by surgery
Bronchoscopic lung volume reduction with valvesProcedure or surgery
Also called BLVR
Lung volume reduction with endobronchial valves.
| Study group | Role | What they receive |
|---|---|---|
| LVRS treatment group | Experimental | 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. Receives: Procedure: Lung volume reduction surgery |
| BLVR study group | Active comparator | 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. Receives: Procedure: Bronchoscopic lung volume reduction with valves |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline value in FEV1 (ml)
Percent change in FEV1
Measured: 6 months after intervention
Secondary outcomes (14)
Change from baseline value in FEV1
Percent change in forced expiratory volume (FEV1)
Measured: 3 and 12 months after intervention
Change from baseline value in RV
Percent change in residual volume (RV)
Measured: 3, 6 and 12 months after intervention
Change from baseline value in TLC
Percent change in total lung capacity (TLC)
Measured: 3, 6 and 12 months after intervention
Change from baseline value in RV/TLC
Percent change in RV-to-TLC ratio
Measured: 3, 6 and 12 months after intervention
Change from baseline value in DLCO
Percent change in diffusion capacity (DLCO)
Measured: 3, 6 and 12 months after intervention
Change from baseline value in 6-minute walking distance
Distance that can be walked within 6 minutes
Measured: 3, 6 and 12 months after intervention
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
Measured: 3, 6 and 12 months after intervention
Change from baseline in quality of life (SGRQ, EQ-5D-5L)
St. George's Respiratory Questionnaire to assess quality of life
Measured: 3, 6 and 12 months after intervention
Change from baseline regarding pain (PDI score)
Pain Disability Index score
Measured: 3, 6 and 12 months after intervention
Change from baseline regarding pain (VAS)
Pain assessment with visual analog scale (VAS)
Measured: 3, 6 and 12 months after intervention
Incidence of (serious) adverse events / re-interventions
Number and degree of adverse events after intervention
Measured: 3, 6 and 12 months after intervention
30-days mortality
Number of deaths (all causes) 1 month after intervention
Measured: 1 month
90-days mortality
Number of deaths (all causes) 3 months after intervention
Measured: 3 months
Overall survival rate
Percentage of patients alive 1 year after intervention
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2020
- Study start1 Sep 2020
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmphysemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- International, multi-center, open label, morphology- and site-stratified, 1:1 randomized, actively controlled
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Isabelle Opitz, Professor, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Isabelle Opitz, Professor, MD, University of Zurich
- Investigators
- Isabelle Opitz, Prof. MD, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04537182
- Sponsor's protocol ID
- SINCERE
- Acronym
- SINCERE
- Status last verified
- May 2024
- First submitted
- 20 Aug 2020
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Compared to Bronchoscopic Lung Volume Reduction in Patients With Severe Emphysema: an International Multi-center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04537182
- Acronym / sponsor ID
- SINCERE / SINCERE
- Conditions
- Emphysema
- Keywords
- LVRS, BLVR, endobronchial valves, heterogeneous empyhsema, non-heterogeneous emphysema
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Isabelle Opitz, Professor, MDUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 3 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- International, multi-center, open label, morphology- and site-stratified, 1:1 randomized, actively controlled
| Arm | Type | Receives |
|---|---|---|
| LVRS treatment group | Experimental | Procedure: Lung volume reduction surgeryA 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. |
| BLVR study group | Active comparator | Procedure: Bronchoscopic lung volume reduction with valvesUnilateral 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. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (20 listed)
- 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%)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lung volume reduction surgeryAlso: LVRSLung volume reduction by surgery | Procedure or surgery | LVRS treatment group |
| Bronchoscopic lung volume reduction with valvesAlso: BLVRLung volume reduction with endobronchial valves. | Procedure or surgery | BLVR study group |
Primary outcome
Change from baseline value in FEV1 (ml)
Time frame: 6 months after intervention
Percent change in FEV1
14 secondary outcomes
Change from baseline value in FEV1
Time frame: 3 and 12 months after intervention
Change from baseline value in RV
Time frame: 3, 6 and 12 months after intervention
Change from baseline value in TLC
Time frame: 3, 6 and 12 months after intervention
Change from baseline value in RV/TLC
Time frame: 3, 6 and 12 months after intervention
Change from baseline value in DLCO
Time frame: 3, 6 and 12 months after intervention
Change from baseline value in 6-minute walking distance
Time frame: 3, 6 and 12 months after intervention
Change from baseline value in mMRC dyspnea score
Time frame: 3, 6 and 12 months after intervention
Change from baseline in quality of life (SGRQ, EQ-5D-5L)
Time frame: 3, 6 and 12 months after intervention
Change from baseline regarding pain (PDI score)
Time frame: 3, 6 and 12 months after intervention
Change from baseline regarding pain (VAS)
Time frame: 3, 6 and 12 months after intervention
Incidence of (serious) adverse events / re-interventions
Time frame: 3, 6 and 12 months after intervention
30-days mortality
Time frame: 1 month
90-days mortality
Time frame: 3 months
Overall survival rate
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Isabelle Opitz, Prof. MD principal investigator
University of Zurich
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lung volume reduction surgery and Bronchoscopic lung volume reduction with valves in people with Emphysema, run by Isabelle Opitz, Professor, MD at 6 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Switzerland, Austria, Belgium, Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Isabelle Opitz, Prof. MD (+41 44 255 11 11, isabelle.schmitt-opitz@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline value in FEV1 (ml) (time frame: 6 months after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.