LVRS Versus BLVR in Patients With Homogenous Emphysema, CLUB-HE Trial

NCT04781582 | Unknown DMC

• 1 other identifier: 20-9518-BO
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective randomized clinical trial comparing surgical and bronchoscopic lung volume reduction in patients with advanced homogeneous emphysema suitable for both procedures.

Conditions

Emphysema or COPD

Outcome Measures

Primary Outcomes (1)

• Change in FEV1 compared to baseline (deltaFEV1)

  Percent change in FEV1

  6 months post intervention

Secondary Outcomes (11)

• Change in BODE Index (Body mass index, airflow obstruction, dyspnoea and exercise capacity in chronic obstructive pulmonary disease)

  3, 6 months post intervention

• Change in TLC

  3, 6 months post intervention

• Change in RV

  3, 6 months post intervention

• Change in RV/TLC

  3, 6 months post intervention

• Change in DLCO

  3, 6 months post intervention

Study Arms (2)

Lung volume reduction surgery arm

ACTIVE COMPARATOR

Bilateral videothoracoscopic lung volume reduction surgery by wedge resection. Unilateral procedures are possible in case of severe adhesions or intraoperative instability. In these cases a staged approach with contralateral LVRS within 3 months is possible.

Procedure: Lung volume reduction surgery

Bronchoscopic lung volume reduction arm

ACTIVE COMPARATOR

Primarily unilateral bronchoscopic lung volume reduction by endobronchial valves. If a bilateral procedure is feasible it must be performed within 3 months after the first intervention.

Procedure: Bronchoscopic lung volume reduction

Interventions

Lung volume reduction surgery PROCEDURE

Surgical lung volume reduction

Lung volume reduction surgery arm

Bronchoscopic lung volume reduction PROCEDURE

Bronchoscopic lung volume reduction by endobronchial valves

Bronchoscopic lung volume reduction arm

Eligibility Criteria

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

You may qualify if:

• COPD III-IV
• Age ≥ 18 years
• FEV1 \< 50% predicted after bronchodilatation
• Significant hyperinflation (TLC \>100% predicted, RV \> 200% predicted, RV/TLC \> 60%)
• Non-smoker or ex-smoker for \> 3 months (documented by cotinine testing)
• MWT \>150 m and ≤ 450m
• MRC dyspnea score \> 3
• Homogenous emphysema as assessed by HR-CT (\< 15% difference in emphysema destruction score between target lobe and ipsilateral lobe) \[16, 17\]
• Uni- or bilateral collateral ventilation (CV) negative result assessed fissure completeness\>95% in QCT and confirmed by a bronchoscopic procedure (Chartis©)
• Optimal medical therapy for \> 3months, sufficient rehabilitation status with no need for further training/rehabilitation or rehabilitation within 6 months prior to intervention.
• Body Mass Index (BMI) \> 18, but \< 35 kg/m2
• Daily dose of prednisone ≤ 10mg

You may not qualify if:

• Contraindication against either LVRS or BLVR and/or to surgery and bronchoscopy in general
• Major comorbidities limiting survival
• Age ≥ 80 years
• Nicotine abuse within 3 months (documented by cotinine testing)
• Predominance of either left or right lung of \>70% in perfusion SPECT scintigraphy
• FEV1 and/or DLCO \<20% predicted (post bronchodilatation)
• Untreated Hypoxemia (PaO2 \< 50 mmHg)
• Untreated Hypercapnia (PaCO2 \> 50 mmHg)
• Significant pulmonary fibrosis or bronchiectasis
• Destroyed/vanished lung on HR-CT
• Previous chest surgery or bronchoscopic interventions
• Pulmonary hypertension (sPAP \> 35 mmHg)
• Active waiting list for lung transplantation
• Patient is not able to understand and willing to sign a written informed consent document.
• Pregnancy

Sponsors & Collaborators

• Universität Duisburg-Essen: lead

Study Sites (1)

University Medicine Essen

Essen, North Rhine-Westphalia, 45239, Germany

RECRUITING

MeSH Terms

Conditions

Emphysema; Pulmonary Disease, Chronic Obstructive

Interventions

Pneumonectomy

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes

Intervention Hierarchy (Ancestors)

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

Study Officials

• Clemens Aigner, Prof. MD

  Universität Duisburg-Essen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clemens Aigner, Prof. MD

CONTACT

+49201433; clemens.aigner@rlk.uk-essen.de

Kaid Darwiche, Prof. MD

CONTACT

+49201433; kaid.darwiche@rlk.uk-essen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Thoracic Surgery

Model Details: single center, 1:1 randomized, open label, controlled

Study Record Dates

• First Submitted: February 25, 2021
• First Posted: March 4, 2021
• Study Start: June 8, 2021
• Primary Completion: May 1, 2024
• Study Completion: November 1, 2024
• Last Updated: September 28, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)