Endoscopic Long Volume Reduction by Endobronchial Valves in Belgium

NCT03264768 | Unknown

• 1 other identifier: s60207
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This a single center non-randomised non-sham controlled intervention study evaluating the effectiveness and safety of endoscopic lung volume reduction by endobronchial valves

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

valves; Chronic Obstructive Pulmonary Disease; endoscopic long volume reduction

Outcome Measures

Primary Outcomes (1)

• response rate of FEV1 at 3 months post intervention

  proportion of patients with a minimal change of FEV1 \> 100 ml

  3 months

Secondary Outcomes (5)

• response rate on SGRQ at 3 months and 6 months post intervention

  3 months and 6 months post intervention

• response rate on 6 minutes walking distance (6MWD) at 3 months and 6 months post intervention

  3 months and 6 months post intervention

• response rate on residual volume (RV) at 3 months and 6 months post intervention

  3 months and 6 months post intervention

• response rate on FEV1 at 6 months post intervention

  6 months

• response rate on Transitional dyspnee index (TDI) at 3 months and 6 months post intervention

  3 months and 6 months post intervention

Other Outcomes (12)

• Change in FEV1 (liters), FVC (liters), RV (liters), TLC (liters) at 3 and 6 months post intervention

  3 months and 6 months post intervention

• Change in RV/TLC ratio (%) at 3 and 6 months post intervention

  3 months and 6 months post intervention

• Change in 6MWD (meters) at 3 and 6 months post intervention

  3 months and 6 months post intervention

Study Arms (2)

control

OTHER

standard care in case collateral ventilation is observed (by Chartis) with 3 months physical activity tele coaching between 3 and 6 months post allocation.

Behavioral: physical activity tele coaching; Procedure: Lung volume reduction surgery (LVRS)

Endobronchial valves

EXPERIMENTAL

Endobronchial valves in case collateral ventilation is absent (by Chartis) with 3 months physical activity tele coaching between 3 and 6 months post intervention.

Device: endobronchial valves; Behavioral: physical activity tele coaching; Procedure: Lung volume reduction surgery (LVRS)

Interventions

endobronchial valves DEVICE

A ambulatory diagnostic bronchoscopy under general anesthesia will evaluate the presence or absence of collateral ventilation . The targeted lobar airway is temporarily occluded by means of a balloon catheter, which blocks inspiratory flow but allows expiratory flow, in order to assess whether the air flow gradually declines to zero, meaning absence of collateral ventilation. Only in case collateral ventilation is excluded, a therapeutic bronchoscopy will be scheduled to insert the one-directional endobronchial valves in the targeted lobar airways. We will only perform a unilateral intervention during which we will treat one or maximal two lobes at one side.

Endobronchial valves

physical activity tele coaching BEHAVIORAL

3 month physical activity tele coaching intervention consisting of a project tailored smartphone application in combination with a step counter providing direct feedback.

Endobronchial valves; control

Lung volume reduction surgery (LVRS) PROCEDURE

Patients not eligible for endoscopic lung volume reduction (or non responders of this intervention) can be referred for surgical lung volume reduction. With this procedure, the most emphysematous parts of the lungs will be surgically removed.

Endobronchial valves; control

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 40 - 75 years
• Confluent or destructive heterogeneous emphysema on CT
• Smoking cessation for at least 6m (proven by urinary cotinine levels)
• FEV1 \< 60 %predicted, RV \> 150 %predicted, TLC \> 90 %predicted
• RV/TLC ratio ≥ 0.55
• MWD \< 450 meter
• mMRC ≥ 2
• Visual estimation of 70% complete fissure between target lobe and adjacent lobe on CT of referring physician
• LABA-LAMA bronchodilator therapy as a minimum therapy
• Able to sign informed consent

You may not qualify if:

• Homogenous emphysema
• PaCO2 \> 60 mmHg with ambient air
• PaO2 \< 45 mmHg with ambient air
• Previous LVRS, lung transplantation, lobectomy
• TLCO or FEV1 \< 20% predicted
• Significant pulmonary hypertension (PaPsyst \> 50 mm Hg)
• Heart failure with reduced EF (\< 40%)
• MWD \< 100 meter
• BODE index ≥ 7 and eligible for transplantation
• Active cancer
• Life expectancy \< 3 months
• Significant lung disease other than COPD/emphysema
• Unable to comply with study procedures

Sponsors & Collaborators

• KU Leuven: lead

Study Sites (1)

UZ Leuven

Leuven, Flanders, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Pneumonectomy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Wim Janssens, MD

  University hospital Leuven, Belgium

  PRINCIPAL INVESTIGATOR

• Dooms Christophe, MD

  University Hospial Leuven, Belgium

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karen Denaux, sc, nurse

CONTACT

016 34 19 66; karen.denaux@uzleuven.be

Kristien De Bent, sc

CONTACT

016 34 17 01; krisiten.debent@uzleuven.be

Study Design

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

Study Record Dates

• First Submitted: August 1, 2017
• First Posted: August 29, 2017
• Study Start: August 1, 2017
• Primary Completion: September 1, 2020
• Study Completion: December 1, 2020
• Last Updated: October 25, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)