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Not yet recruiting NCT07051161

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

— Observational Solid Cancer Bronchial Endoscopy Therapeutic Bronchofiberscopy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: bronchoscope.
Who it may be relevant to
Registry conditions: Solid Cancer, Bronchial Endoscopy, Therapeutic Bronchofiberscopy. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Procedure bronchoscope
    procedure performed by bronchoscopy

Primary outcome measures

  • Saint George Score (quality of life) [Time frame: At inclusion, and 7 days after therapeutic bronchoscopy]
Secondary outcome measures (6)
  • Saint-George and SF-12 (12-Item Short-Form Health Survey) score [Time frame: at inclusion and Day 30]
  • ECOG-performance Status [Time frame: inclusion and Day 30]
  • Duration of ventilatory support (mechanical ventilation, non-invasive ventilation, high-flow oxygen) [Time frame: During the 30 first days from intervention]
  • hospitalization duration [Time frame: During the 30 first days from intervention]
  • anti-tumoral treatment [Time frame: During the 30 first days from intervention]
  • survival [Time frame: through study completion, an average of 1 year]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • 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( PMID 38391185
  • 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 PMID 40188807

Identifiers

NCT: NCT07051161 · 38RC24.0408 · 2024-A02698-39

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗