Effects of Endoscopic Lung Volume Reduction on Diaphragm Function and Conformation

NCT ID: NCT05799352

Last Updated: 2025-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2025-01-30

Brief Summary

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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.

Detailed Description

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Conditions

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COPD

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Before and after study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Endoscopic lung volume reduction

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

Group Type EXPERIMENTAL

Endoscopic lung volume reduction

Intervention Type 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.

Interventions

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Endoscopic lung volume reduction

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* valves insertion

Exclusion Criteria

* TLVR \< 50 %
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Erasme University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Olivier Taton

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Olivier Taton

Role: PRINCIPAL_INVESTIGATOR

Hôpital Erasme, Université Libre de Brussels, Brussels, Belgium

Locations

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Erasme Hospital

Brussels, Brussels Capital, Belgium

Site Status

Countries

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Belgium

References

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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 Jul 23;88:101194. doi: 10.1016/j.resmer.2025.101194. Online ahead of print.

Reference Type DERIVED
PMID: 40763652 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38914469 (View on PubMed)

Other Identifiers

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P2018/227

Identifier Type: -

Identifier Source: org_study_id

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