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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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07051161
Acronym
ENDoRA
Enrollment
60
Registered
2025-07-04
Start date
2025-08-01
Completion date
2026-12-01
Last updated
2025-07-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchial Endoscopy, Solid Cancer, Therapeutic Bronchofiberscopy

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.

Interventions

PROCEDUREbronchoscope

procedure performed by bronchoscopy

Sponsors

University Hospital, Grenoble
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Saint George Score (quality of life)At inclusion, and 7 days after therapeutic bronchoscopyDifference 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

MeasureTime frameDescription
ECOG-performance Statusinclusion and Day 30It 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
Saint-George and SF-12 (12-Item Short-Form Health Survey) scoreat inclusion and Day 30Difference 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.
anti-tumoral treatmentDuring the 30 first days from interventioninitiation or continuation of anti-tumour treatment (radiotherapy, chemotherapy, immunotherapy, targeted therapy)
survivalthrough study completion, an average of 1 year
hospitalization durationDuring the 30 first days from intervention

Contacts

Primary ContactAnne-Claire Toffart, MD-PhD
atoffart@chu-grenoble.fr+33476766831

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026