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Efficacy and Safety of Endoscopic the Over-The-Scope Clip (OTSC) combined with Autologous Platelet-Rich Plasma Injection for Acquired Benign Esophageal-Respiratory Fistulas: An Observational Study

Efficacy and Safety of Endoscopic the Over-The-Scope Clip (OTSC) combined with Autologous Platelet-Rich Plasma Injection for Acquired Benign Esophageal-Respiratory Fistulas: An Observational Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600123508
Enrollment
Unknown
Registered
2026-04-27
Start date
2026-04-30
Completion date
Unknown
Last updated
2026-05-04

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

Conditions

acquired benign esophageal-respiratory fistulas

Interventions

Group B (Fistula orifice maximum diameter 1-2 cm):Endoscopic submucosal injection of autologous platelet-rich plasma and/or Over-The-Scope Clip (OTSC) closure procedure
Group A (fistula orifice maximum diameter < 1 cm):Endoscopic submucosal injection of autologous platelet-rich plasma and/or Over-The-Scope Clip (OTSC) closure procedure

Sponsors

Emergency General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 18 to 80 years were included. 2. Patients with a confirmed diagnosis of acquired benign esophageal-respiratory fistulas (ABERFs) by gastroscopy, bronchoscopy, or imaging studies were included.

Exclusion criteria

Exclusion criteria: 1. Fistula orifice >20 mm in maximum diameter; 2. Coagulopathy or bleeding disorders; 3. Severe cardiac/pulmonary dysfunction; 4. Contraindication to or refusal of endoscopic OTSC/auto-PRP therapy; 5. Thoracic radiotherapy or chemotherapy within the last 2 months; 6. Investigator’s judgment of unsuitability.

Design outcomes

Primary

MeasureTime frame
the clinical healing rate of endoscopic treatment for acquired benign esophageal-respiratory fistulas;

Secondary

MeasureTime frame
the incidence of adverse reactions to endoscopic treatment for acquired benign esophageal-respiratory fistulas;the mean length of hospital stay and cost associated with endoscopic treatment for acquired benign esophageal-respiratory fistulas;the technical success rate of endoscopic treatment for acquired benign esophageal-respiratory fistulas;

Countries

China

Contacts

Public ContactXiaochuan Liu

Emergency General Hospital

hrzyr.student@sina.com+86 10 87935333

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 7, 2026