Aerodigestive FistulasFAD'HUSNCT07299513
Aerodigestive Fistulas in Adults at the University Hospital of Strasbourg
An observational study of Aerodigestive Fistulas, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Acquired aerodigestive fistulas in adults are rare conditions, corresponding to a pathological communication between the digestive and respiratory tracts, requiring collaborative multidisciplinary management. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aerodigestive Fistulas
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 21 Nov 2024to 21 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Adult subject with a fAerodigestive fistula between January 1, 2014, and December 31, 2023
Who may be able to join
- 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)
Who cannot join
- Explicit refusal by the patient to provide their data
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service de Pneumologie - Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
Guillaume PAMART, MD, 33 3/69/55/06/48, guillaume.pamart@chru-strasbourg.fr
Guillaume PAMART, MD
About this study
Official title: Aerodigestive Fistulas in Adults: Management at the Strasbourg University Hospital Between 2014 and 2023
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).
- Conditions
- Aerodigestive Fistulas
- Keywords
- Aerodigestive fistulas, Endoscopic investigations, Thoracic cancer, Oncological disease, Malignant fistula
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival rate since diagnosis
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study start21 Nov 2024
- Primary completionNov 2026 (estimated)
- Study completion21 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aerodigestive FistulasStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07299513
- Sponsor's protocol ID
- 9376
- Acronym
- FAD'HUS
- Status last verified
- Dec 2025
- First submitted
- 9 Dec 2025
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aerodigestive Fistulas in Adults: Management at the Strasbourg University Hospital Between 2014 and 2023
- ClinicalTrials.gov ID
- NCT07299513
- Acronym / sponsor ID
- FAD'HUS / 9376
- Conditions
- Aerodigestive Fistulas
- Keywords
- Aerodigestive fistulas, Endoscopic investigations, Thoracic cancer, Oncological disease, Malignant fistula
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 21 Nov 2024 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- 21 Nov 2026 (estimated)
- First posted
- 23 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult subject with a fAerodigestive fistula between January 1, 2014, and December 31, 2023
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (1 listed)
- Explicit refusal by the patient to provide their data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall survival rate since diagnosis
Time frame: Up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aerodigestive Fistulas, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guillaume PAMART, MD (33 3/69/55/06/48, guillaume.pamart@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival rate since diagnosis (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.