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

NCT04537182 | Recruiting

• 1 other identifier: SINCERE
• Study Type: interventional
• Target: 120
• Locations: 4 countries
• Sites: 6

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.

Conditions

Emphysema

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change from baseline value in FEV1 (ml)

  Percent change in FEV1

  6 months after intervention

Secondary Outcomes (14)

• Change from baseline value in FEV1

  3 and 12 months after intervention

• Change from baseline value in RV

  3, 6 and 12 months after intervention

• Change from baseline value in TLC

  3, 6 and 12 months after intervention

• Change from baseline value in RV/TLC

  3, 6 and 12 months after intervention

• Change from baseline value in DLCO

  3, 6 and 12 months after intervention

Study Arms (2)

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.

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.

Procedure: Bronchoscopic lung volume reduction with valves

Interventions

Lung volume reduction surgery PROCEDURE

Lung volume reduction by surgery

Also known as: LVRS

LVRS treatment group

Bronchoscopic lung volume reduction with valves PROCEDURE

Lung volume reduction with endobronchial valves.

Also known as: BLVR

BLVR study group

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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%)
• 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

Sponsors & Collaborators

• Isabelle Opitz, Professor, MD: lead

Study Sites (6)

Universitätsklinik für Thoraxchirurgie, Medical University of Vienna

Vienna, Austria

RECRUITING

University Hospital Leuven

Leuven, 3000, Belgium

RECRUITING

Rigshospitalet, University of Copenhagen

Copenhagen, 2100, Denmark

RECRUITING

Kantonsspital Aarau

Aarau, Canton of Aargau, 5001, Switzerland

RECRUITING

Lausanne University Hospital (CHUV)

Lausanne, Canton of Vaud, 1011, Switzerland

RECRUITING

University Hospital Zurich, Division of Thoracic Surgery

Zurich, Canton of Zurich, 8091, Switzerland

RECRUITING

MeSH Terms

Conditions

Emphysema

Interventions

Pneumonectomy

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative; Pulmonary Surgical Procedures; Thoracic Surgical Procedures

Study Officials

• Isabelle Opitz, Prof. MD

  University of Zurich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Isabelle Opitz, Prof. MD

CONTACT

+41 44 255 11 11; isabelle.schmitt-opitz@usz.ch

Albana Rexhepaj, PhD

CONTACT

+41 44 255 92 30; Albana.RexhepajBaumann@usz.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. MD

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

Study Record Dates

• First Submitted: August 20, 2020
• First Posted: September 3, 2020
• Study Start: September 1, 2020
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); DK (1); CH (3); BE (1)