Impact of Interventional Endoscopy on Quality of Life in Patients With Acute Respiratory Distress Due to Tumor Compression or Obstruction of the Lower Respiratory Tract

NCT ID: NCT07051161

Last Updated: 2025-07-04

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

NOT_YET_RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-08-01

Study Completion Date

2026-12-01

Brief Summary

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Bronchoscopic endoscopy has shown its effectiveness and reliability for the treatment (desobstruction or prothesis) of tumor-induced bronchial obstructions, particularly in the first few weeks. The presence of a lower airway prosthesis can lead to device obstruction requiring daily inhaled fluidification, bacterial colonization, migration of the prosthesis, or the appearance of obstructive or hemorrhagic granulomas.

The aim of this study is to evaluate the quality of life of patients after endobronchial treatment.

It is a prospective, descriptive, and multicentric (national) study. The main objective is to compare the total score on the Saint-George questionnaire at J7 of the interventional endoscopy compared to before the procedure.

Detailed Description

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Conditions

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Solid Cancer Bronchial Endoscopy Therapeutic Bronchofiberscopy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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bronchoscope

procedure performed by bronchoscopy

Intervention Type PROCEDURE

Other Intervention Names

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desobstruction of lower respiratory tract

Eligibility Criteria

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Inclusion Criteria

* \>18 years old
* tumoral tracheobronchial obstruction and/or compression
* proven solid cancer or suspicion
* Acute respiratory distress (at least one of the 5):

* RR : ≥25/min
* Sign of respiratory struggle
* Sign of respiratory failure
* Oxygen therapy ≥5L/min
* Ventilatory support (NIV, OHD or IT) :
* Indication for therapeutic interventional endoscopy
* No guardianship or curatorship
* Non-hematological tumor

Exclusion Criteria

* Minors
* patients with neurological disabilities unable to understand and respond to the questionnaire
* patients under guardianship or curatorship
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Anne-Claire Toffart, MD-PhD

Role: CONTACT

+33476766831

References

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Roy P, Fournier C, Barnestein R, Wallyn F, Bourinet V, Briault A, Camuset J, Cellerin L, Crutu A, Dewolf M, Egenod T, Favrolt N, Heluain V, Lorut C, Mangiapan G, Schlossmasscher P, Toublanc B, Usturoi D, Legodec J, Vergnon JM, Pajiep Chapda MC, Dutau H, Guibert N. Outcomes of Therapeutic Bronchoscopy in Malignant Airway Obstruction Causing Acute Respiratory Failure. Ann Am Thorac Soc. 2024 May;21(5):833-837. doi: 10.1513/AnnalsATS.202311-943RL. No abstract available.

Reference Type BACKGROUND
PMID: 38391185 (View on PubMed)

Roy P, Roy P, Amari L, Laroumagne S, Legodec J, Fournier C, Cellerin L, Lorut C, Gonin F, Vergnon JM, Egenod T, Favrolt N, Schlossmacher P, Bourinet V, Perrot L, Lachkar S, Camuset J, Briault A, Degot T, Gut-Gobert C, Mangiapan G, Jasnot JY, Briens E, Crutu A, Marceau A, Toublanc B, Dewolf M, Dutilh J, Germain N, Tronchetti J, Astoul P, Guibert N, Dutau H. Predictive Factors of Clinical Success of Therapeutic Bronchoscopy in Malignant Central Airway Obstruction: Results from the EpiGETIF Registry. Respiration. 2025;104(9):667-677. doi: 10.1159/000545568. Epub 2025 Apr 4.

Reference Type BACKGROUND
PMID: 40188807 (View on PubMed)

Other Identifiers

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2024-A02698-39

Identifier Type: OTHER

Identifier Source: secondary_id

38RC24.0408

Identifier Type: -

Identifier Source: org_study_id

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