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

NCT07051161 | Not Yet Recruiting

• 2 other identifiers: 38RC24.04082024-A02698-39
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Solid Cancer; Bronchial Endoscopy; Therapeutic Bronchofiberscopy

Outcome Measures

Primary Outcomes (1)

• Saint George Score (quality of life)

  Difference between Saint-George score at inclusion and Day 7. The scores for each dimension range from 0 to 100, with a score of 100 indicating excellent health.

  At inclusion, and 7 days after therapeutic bronchoscopy

Secondary Outcomes (6)

• Saint-George and SF-12 (12-Item Short-Form Health Survey) score

  at inclusion and Day 30

• ECOG-performance Status

  inclusion and Day 30

• Duration of ventilatory support (mechanical ventilation, non-invasive ventilation, high-flow oxygen)

  During the 30 first days from intervention

• hospitalization duration

  During the 30 first days from intervention

• anti-tumoral treatment

  During the 30 first days from intervention

Interventions

bronchoscope PROCEDURE

procedure performed by bronchoscopy

Also known as: desobstruction of lower respiratory tract

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• \>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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Related Publications (2)

• 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.

  PMID: 38391185 BACKGROUND

• 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.

  PMID: 40188807 BACKGROUND

MeSH Terms

Interventions

Bronchoscopes

Intervention Hierarchy (Ancestors)

Endoscopes; Diagnostic Equipment; Equipment and Supplies; Surgical Equipment

Central Study Contacts

Anne-Claire Toffart, MD-PhD

CONTACT

+33476766831; atoffart@chu-grenoble.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2025
• First Posted: July 4, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 4, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share