Prospective observational study investigating the safety and efficacy of airway stent for tracheoesophageal and bronchial esophageal fistula

Prospective observational study investigating the safety and efficacy of airway stent for tracheoesophageal and bronchial esophageal fistula - Safety and efficacy of airway stent for tracheoesophageal fistula

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000047454

Enrollment

Registered

2022-04-11

Start date

2022-04-12

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Tracheoesophageal and bronchial esophageal fistula

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Patients with fistula between the central airway and esophagus who are expected to show symptom improvement 2)Patients who are expected to restart eating after airway stenting 3)Patients who are expected to survive for more than one month 4)20 years or older 5)Informed consent

Exclusion criteria

Exclusion criteria: 1)It is difficult to start eating because of esophageal obstruction or consciousness disorder, etc. 2)Patients with difficulty eating because of performance status 3)Patients who have difficulty answering VAS

Design outcomes

Primary

Measure	Time frame
To evaluate whether the patients can eat solid food at 30 days after airway stenting	—

Secondary

Measure	Time frame
1.To check whether fistula is still persistent after airway stenting 2.To evaluate the safety of the procedure (e.g. pneumonia, bleeding, deviation and so on) 3.To evaluate the visual analog scale (VAS) of symptoms 4.If it complicated pneumonia before stenting, it will be improved or not 5.The survival time after airway stenting	—

Countries

Japan

Contacts

Public ContactAtsushi Torii

National Hospital Organization Nagoya Medical Center Department of Respiratory Medicine

a51009068@gmail.com052-951-1111

Outcome results