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

Primary Purpose

Emphysema

Status

Recruiting

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Lung volume reduction surgery

Bronchoscopic lung volume reduction with valves

About this trial

This is an interventional treatment trial for Emphysema focused on measuring LVRS, BLVR, endobronchial valves, heterogeneous empyhsema, non-heterogeneous emphysema

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University Hospital LeuvenRecruiting
Kantonsspital AarauRecruiting
Lausanne University Hospital (CHUV)Recruiting
University Hospital Zurich, Division of Thoracic SurgeryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

LVRS treatment group

BLVR study group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change from baseline value in FEV1 (ml)

Percent change in FEV1

Secondary Outcome Measures

Change from baseline value in FEV1

Percent change in forced expiratory volume (FEV1)

Change from baseline value in RV

Percent change in residual volume (RV)

Change from baseline value in TLC

Percent change in total lung capacity (TLC)

Change from baseline value in RV/TLC

Percent change in RV-to-TLC ratio

Change from baseline value in DLCO

Percent change in diffusion capacity (DLCO)

Change from baseline value in 6-minute walking distance

Distance that can be walked within 6 minutes

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

Change from baseline in quality of life (SGRQ, EQ-5D-5L)

St. George's Respiratory Questionnaire to assess quality of life

Change from baseline regarding pain (PDI score)

Pain Disability Index score

Change from baseline regarding pain (VAS)

Pain assessment with visual analog scale (VAS)

Incidence of (serious) adverse events / re-interventions

Number and degree of adverse events after intervention

30-days mortality

Number of deaths (all causes) 1 month after intervention

90-days mortality

Number of deaths (all causes) 3 months after intervention

Overall survival rate

Percentage of patients alive 1 year after intervention

Full Information

NCT ID

NCT04537182

First Posted

August 20, 2020

Last Updated

May 23, 2022

Sponsor

Isabelle Opitz, Professor, MD

1. Study Identification

Unique Protocol Identification Number

NCT04537182

Brief Title

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

Acronym

SINCERE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Recruiting

Study Start Date

September 1, 2020 (Actual)

Primary Completion Date

November 2023 (Anticipated)

Study Completion Date

November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Isabelle Opitz, Professor, MD

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Emphysema

Keywords

LVRS, BLVR, endobronchial valves, heterogeneous empyhsema, non-heterogeneous emphysema

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

International, multi-center, open label, morphology- and site-stratified, 1:1 randomized, actively controlled

Masking

None (Open Label)

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

LVRS treatment group

Arm Type

Experimental

Arm Description

Arm Title

BLVR study group

Arm Type

Active Comparator

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Lung volume reduction surgery

Other Intervention Name(s)

LVRS

Intervention Description

Lung volume reduction by surgery

Intervention Type

Procedure

Intervention Name(s)

Bronchoscopic lung volume reduction with valves

Other Intervention Name(s)

BLVR

Intervention Description

Lung volume reduction with endobronchial valves.

Primary Outcome Measure Information:

Title

Change from baseline value in FEV1 (ml)

Description

Percent change in FEV1

Time Frame

6 months after intervention

Secondary Outcome Measure Information:

Title

Change from baseline value in FEV1

Description

Percent change in forced expiratory volume (FEV1)

Time Frame

3 and 12 months after intervention

Title

Change from baseline value in RV

Description

Percent change in residual volume (RV)

Time Frame