Effects of Endoscopic Lung Volume Reduction on Diaphragm Function and Conformation

NCT05799352 | Completed

• 1 other identifier: P2018/227
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic obstructive lung disease (COPD) is a common disease that is frequently complicated by hyperinflation. The resulting increase in lung volume impairs the diaphragmatic function because of a shortening of the diaphragmatic fibers and an increase in the radius of curvature of the diaphragmatic domes. Lung volume reduction surgery (LVRS) has already shown an improvement in diaphragmatic function that could be explained by a change of the diaphragm conformation. More recently, endoscopic lung volume reduction (ELVR) has shown benefits in terms of respiratory function, exercise capacity and quality of life, but the mechanisms of these improvements are poorly understood. Therefore, we aim to evaluate the evolution of the diaphragmatic function and the changes in diaphragmatic conformation after unilateral ELVR.

Conditions

COPD

Outcome Measures

Primary Outcomes (2)

• Transdiaphragmatic pressure

  evaluate the difference in diaphragmatic function, assessed by the transdiaphragmatic pressure, before and 3 months after unilateral valves setting

  before until 3 months after the valves insertion

• Diaphragmatic conformation

  evaluate the change of the diaphragm conformation, by measuring diaphragmatic fibers length in several planes, diaphragmatic area and radius of curvature, before and 3 months after unilateral ELVR.

  before until 3 months after the valves insertion

Study Arms (1)

Endoscopic lung volume reduction

EXPERIMENTAL

All the patients will have endobronchial valves insertion. We will evaluate before and 3 months after the evolution of the diaphragmatic strength and conformation.

Device: Endoscopic lung volume reduction

Interventions

Endoscopic lung volume reduction DEVICE

a prospective monocentric study on hyperinflated COPD patients without collateral ventilation. Patients were evaluated before and 3 months after unilateral ELVR by transdiaphragmatic pressure (Pdi) measured at the functional residual capacity (FRC) after magnetic phrenic stimulation and by high-resolution computed tomography at the FRC allowing 3D modelling of the diaphragm for measurements of fibers length, length of the zone of apposition and radius of curvature of the diaphragmatic domes.

Endoscopic lung volume reduction

Eligibility Criteria

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

You may qualify if:

• valves insertion

You may not qualify if:

• TLVR \< 50 %

Sponsors & Collaborators

• Erasme University Hospital: lead

Study Sites (1)

Erasme Hospital

Brussels, Brussels Capital, 1070, Belgium

Location

Related Publications (2)

• Taton O, Perez-Bogerd S, Van Muylem A, Gevenois PA, Van Hove O, Bondue B, Brenard E, Leduc D. Chest mechanics after endoscopic lung volume reduction: Comparison between responders and non-responders based on dynamic hyperinflation. Respir Med Res. 2025 Nov;88:101194. doi: 10.1016/j.resmer.2025.101194. Epub 2025 Jul 23.

  PMID: 40763652 DERIVED

• Taton O, Gevenois PA, Van Muylem A, Bondue B, Van Laethem S, Leduc D. Improvements of the shape and strength of the diaphragm after endoscopic lung volume reduction. Thorax. 2024 Jul 16;79(8):711-717. doi: 10.1136/thorax-2024-221375.

  PMID: 38914469 DERIVED

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

• Olivier Taton

  Hôpital Erasme, Université Libre de Brussels, Brussels, Belgium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: Before and after study

Study Record Dates

• First Submitted: March 23, 2023
• First Posted: April 5, 2023
• Study Start: April 1, 2019
• Primary Completion: January 30, 2025
• Study Completion: January 30, 2025
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)