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, 60 participants, University Hospital, Grenoble

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Registry	NCT07051161, acronym ENDoRA
Status	Not yet recruiting
Study type	Observational
Enrollment	60 (Estimated)
Sponsor	University Hospital, Grenoble (Other)
Conditions	Solid Cancer, Bronchial Endoscopy, Therapeutic Bronchofiberscopy
Interventions	bronchoscope (Procedure)
Dates	start 2025-08-01 (estimated), primary completion 2026-12-01 (estimated), completion 2026-12-01 (estimated), first posted 2025-07-04, last updated 2025-07-04

-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.

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+Arms and interventions

bronchoscope (Procedure), also known as desobstruction of lower respiratory tract: procedure performed by bronchoscopy

+Outcome measures

Primary outcomes

Saint George Score (quality of life) [At inclusion, and 7 days after therapeutic bronchoscopy]: 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.

Secondary outcomes

Saint-George and SF-12 (12-Item Short-Form Health Survey) score [at inclusion and Day 30]: Difference of these scores between inclusion and Day 30 The scores for each dimension of the Saint-George score range from 0 to 100, with a score of 100 indicating excellent health. The SF-12 score ranges from 1 to 60, with a score of 60 indicating very poor quality of life.
ECOG-performance Status [inclusion and Day 30]: It ranges from 0 (fully active) to 5 (dead).
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]: initiation or continuation of anti-tumour treatment (radiotherapy, chemotherapy, immunotherapy, targeted therapy)
survival [through study completion, an average of 1 year]

+Eligibility

Sex: All

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

+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(5):833-837. doi: 10.1513/AnnalsATS.202311-943RL. No abstract available. 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 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