Menu
Recruiting NCT07299513

Aerodigestive Fistulas in Adults at the University Hospital of Strasbourg

Observational Aerodigestive Fistulas

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
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Aerodigestive Fistulas. Basic parameters: from 18 years · 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
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Aerodigestive Fistulas in Adults: Management at the Strasbourg University Hospital Between 2014 and 2023

Overview

Acquired aerodigestive fistulas in adults are rare conditions, corresponding to a pathological communication between the digestive and respiratory tracts, requiring collaborative multidisciplinary management. Clinical manifestations are nonspecific, ranging from a simple cough to pulmonary sepsis, which can be life-threatening. Diagnosis is often multimodal, requiring radiological examinations and endoscopic investigations. The most frequent etiologies are divided into two groups: benign and malignant causes, each group representing 50% of all acquired aerodigestive fistulas. Among the benign etiologies, 75% are iatrogenic, mainly represented by complications related to orotracheal intubation. These fistulas of benign etiology most often have a favorable prognosis, amenable to surgical treatment. Conversely, the development of an aerodigestive fistula in the context of thoracic cancer marks a turning point in the evolution of the oncological disease. Indeed, the average life expectancy of patients with a malignant fistula is estimated at between 1 and 6 weeks without specific treatment. Following this palliative approach aimed at improving quality of life, multiple treatment options are available, often combined with digestive and thoracic endoscopy. The Strasbourg University Hospitals are a leading tertiary care center for these pathologies, with departments of Pulmonology, Gastroenterology, Digestive Surgery, Thoracic Surgery, Medical Intensive Care, Multipurpose Surgical Intensive Care, Bronchial Endoscopy, and Digestive Endoscopy. The centre's influence extends over the entire eastern part of the Grand Est region (Nancy, Metz, Strasbourg, Mulhouse).

Primary outcome measures

  • Overall survival rate since diagnosis [Time frame: Up to 2 years]

Eligibility criteria

Inclusion criteria

  • Age > 18 years at diagnosis
  • Diagnosis between January 1, 2014, and December 31, 2023
  • Aerodigestive fistula defined by one of the following criteria:
  • Fistula visualized by bronchoscopy and/or digestive endoscopy
  • Fistula visualized by static chest imaging (CT scan or MRI)
  • Fistula visualized by dynamic chest imaging (barium swallow)
  • Hospitalization at the Strasbourg University Hospitals (HUS)

Exclusion criteria

  • Explicit refusal by the patient to provide their data

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

Study design

Observational model
Case-control

Study locations

France · 1 center
  • Service de Pneumologie - Hôpitaux Universitaires de Strasbourg — Strasbourg

Identifiers

NCT: NCT07299513 · 9376

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗