Low-output External Gastrointestinal Fistula Clinical Trial
Official title:
A Randomized Controlled Trial to Evaluate Endoscopy Assisted Fibrin Glue Application in the Treatment of Low-Output ECFs
Adjuvant use of fibrin glue (FG) in the fistula tract has been shown to promote closure of low-output ECFs. The primary objectives of this study are to compare the clinical efficacy, safety of autologous platelet-rich fibrin glue (PRFG) and a commercially available fibrin sealant Bioseal® in the management of patients with low-output volume ECFs.
- This is a prospective, randomized, single-centered study clinical, safety and economic
outcome of ECFs patients.
- Subjects are randomized to one of 2 groups:
- Group 1: Autologous PRFG-treatment (PRFG + SOC)
- Group 2: Commercial FG-treatment (Bioseal® + SOC)
- Study will include three phases:
- Phase 1: Screening, consent and enrollment
- Phase 2: Patients will receive either PRFG, or Bioseal only for 14 days
- Phase 3: Follow up: for patients with closed fistula within 14 days, we will
follow up them for 6 months. For patients whose fistulas were still open will be
treated with other therapeutic option and follow up for 6 months after closure.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT01828892 -
Glue Application in the Treatment of Low-Output Fistulas
|
N/A |