Glue Sealing for Patients With Low-Output ECFs

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.

Inclusion Criteria:

• Patients with a single tubular ECF
• Low output volume (<200 ml/24h)
• Tract length >2cm
• Tract diameter < 1cm

Exclusion Criteria:

• Cancer-infiltrated fistula
• Abscess
• Foreign bodies
• Distal bowel obstruction
• Inflammatory bowel disease