The efficacy and safety of a novel gastrointestinal occluder in the treatment of refractory upper gastrointestinal-tracheobronchial fistulas

A prospective study of a novel occluder for endoscopic closure of refractory upper gastrointestinal-tracheobronchial fistulas

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000038566

Enrollment

Unknown

Registered

2020-09-24

Start date

2020-09-24

Completion date

Unknown

Last updated

2022-11-07

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

Conditions

upper gastrointestinal-tracheobronchial fistulas

Interventions

occluding treatment group:Insertion of gastrointestinal occluder

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18–80 years; 2. Benign chronic upper gastrointestinal-tracheobronchial fistula (defined as duration >3 months); 3. Failure of previous conservative management and conventional endoscopic treatments; 4. Unwilling or unable to undergo surgical operations.

Exclusion criteria

Exclusion criteria: 1. Local ulcer; 2. Coagulation dysfunction (international normalized ratio >1.5 or platelet count <50000/mm3 or undergoing Antithrombotic therapy); 3. Severe cardiac or cerebrovascular diseases (unstable angina, myocardial infarction, heart failure, cerebrovascular accident or transient ischemic attack within 6 months); 4. History of mental illness; 5. Pregnancy; 6. Unable to tolerate general anesthesia.

Design outcomes

Primary

Measure	Time frame
effectively closed;Autonomous diet;Complications;	—

Secondary

Measure	Time frame
BMI;health-related quality of life;technical success rate;	—

Countries

China

Contacts

Public ContactGuoxin Zhang

The First Affiliated Hospital of Nanjing Medical University

Guoxinz@njmu.edu.com+86 25 68303142

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 12, 2026