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

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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Key information

Conditions

Solid Cancer Bronchial Endoscopy Therapeutic Bronchofiberscopy

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bronchoscope

Procedure

procedure performed by bronchoscopy

Other names: desobstruction of lower respiratory tract

Primary outcomes

Saint George Score (quality of life)

Time frame: 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

Time frame: 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

Time frame: 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)

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

initiation or continuation of anti-tumour treatment (radiotherapy, chemotherapy, immunotherapy, targeted therapy)
survival

Time frame: through study completion, an average of 1 year

Study contacts

Contact information is provided by the study sponsor or research team.

Anne-Claire Toffart, MD-PhD

CONTACT

[email protected]

+33476766831

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Acronym: ENDoRA

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Jul 4, 2025
Registry last updated: Jul 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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