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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
Sponsor:
Information provided by (Responsible Party):
Isabelle Opitz, Professor, MD, University of Zurich

Brief 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.

Condition or disease Intervention/treatment Phase
Emphysema Procedure: Lung volume reduction surgery Procedure: Bronchoscopic lung volume reduction with valves Not Applicable

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Emphysema

Arm Intervention/treatment
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.
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.
Procedure: Bronchoscopic lung volume reduction with valves
Lung volume reduction with endobronchial valves.
Other Name: BLVR




Primary Outcome Measures :
  1. Change from baseline value in FEV1 (ml) [ Time Frame: 6 months after intervention ]
    Percent change in FEV1


Secondary Outcome Measures :
  1. Change from baseline value in FEV1 [ Time Frame: 3 and 12 months after intervention ]
    Percent change in forced expiratory volume (FEV1)

  2. Change from baseline value in RV [ Time Frame: 3, 6 and 12 months after intervention ]
    Percent change in residual volume (RV)

  3. Change from baseline value in TLC [ Time Frame: 3, 6 and 12 months after intervention ]
    Percent change in total lung capacity (TLC)

  4. Change from baseline value in RV/TLC [ Time Frame: 3, 6 and 12 months after intervention ]
    Percent change in RV-to-TLC ratio

  5. Change from baseline value in DLCO [ Time Frame: 3, 6 and 12 months after intervention ]
    Percent change in diffusion capacity (DLCO)

  6. 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

  7. 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

  8. 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

  9. Change from baseline regarding pain (PDI score) [ Time Frame: 3, 6 and 12 months after intervention ]
    Pain Disability Index score

  10. Change from baseline regarding pain (VAS) [ Time Frame: 3, 6 and 12 months after intervention ]
    Pain assessment with visual analog scale (VAS)

  11. Incidence of (serious) adverse events / re-interventions [ Time Frame: 3, 6 and 12 months after intervention ]
    Number and degree of adverse events after intervention

  12. 30-days mortality [ Time Frame: 1 month ]
    Number of deaths (all causes) 1 month after intervention

  13. 90-days mortality [ Time Frame: 3 months ]
    Number of deaths (all causes) 3 months after intervention

  14. Overall survival rate [ Time Frame: 12 months ]
    Percentage of patients alive 1 year after intervention



Information from the National Library of Medicine

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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
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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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

Locations
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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   
Sponsors and Collaborators
Isabelle Opitz, Professor, MD
Investigators
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Principal Investigator: Isabelle Opitz, Prof. MD University of Zurich
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Isabelle Opitz, Professor, MD, University of Zurich:
LVRS
BLVR
endobronchial valves
heterogeneous empyhsema
non-heterogeneous emphysema
Additional relevant MeSH terms:
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Pulmonary Emphysema
Emphysema
Pathologic Processes
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases