跳至主要内容
临床试验/NCT07299513
NCT07299513招募中不适用

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

University Hospital, Strasbourg, France1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年11月21日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
Overall survival rate since diagnosis

研究概览

简要总结

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).

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • Explicit refusal by the patient to provide their data

结局指标

主要结局

Overall survival rate since diagnosis

时间窗: Up to 2 years

次要结局

未报告次要终点

研究者

发起方
University Hospital, Strasbourg, France
申办方类型
Other
责任方
Sponsor

研究点 (1)

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