Glue Application in the Treatment of Low-Output Fistulas (FG-treatment)

Jinling Hospital, China

Status: Unknown

Conditions: Low-output External Gastrointestinal Fistula

Treatments: Dietary Supplement: Nutrition support; Drug: Antibiotics (ceftazidime, cefotaxime, or meropenem, with or without vancomycin); Procedure: Endoscopy exploration; Procedure: Endoscopy exploration and glue application

Study type: Interventional

Funder types: Other

Identifiers

NCT01828892

20120819

Details and patient eligibility

About

Adjuvant use of fibrin glue (FG) in the fistula tract has been shown to promote closure of low-output enterocutaneous fistulas (ECFs). The primary objectives of this study are to compare the clinical efficacy, safety of autologous platelet-rich fibrin glue (PRFG), commercial fibrin glue, and control therapy in the management of patients with low-output volume ECFs.

Full description

• This is a prospective, randomized, multi-centered study clinical, safety and economic outcome of ECFs patients.

• Subjects are randomized to one of 3 groups:

  • Group 1: Autologous PRFG-treatment [PRFG + Standard of care (SOC)]
  • Group 2: Commercial FG-treatment [FG + Standard of care (SOC)]
  • Group 3: Control (SOC only)

• Study will include three phases:

  • Phase 1: Screening, consent and enrollment
  • Phase 2: Patients will receive either PRFG, commercial FG, or SOC 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

PRFG treatment

Experimental group

Description:

As described in our previous study, platelet-rich cryoprecipitate and thrombin were obtained from 300-400ml whole blood of each patient enrolled in the PRFG group and then frozen at -20°C for storage. Prior to application, frozen cryoprecipitate and thrombin stored were thawed in a 37°C water bath. Aminomethylbenzoic Acid (1ml: 1mg, Sigma-Aldrich, St Louis, MO) was added into the cryoprecipitate in the volume ratio of 1:10.

Treatment:

Procedure: Endoscopy exploration and glue application

Drug: Antibiotics (ceftazidime, cefotaxime, or meropenem, with or without vancomycin)

Dietary Supplement: Nutrition support

Control

Sham Comparator group

Description:

Patients in this group only received standard of care when their fistula output \< 200ml/24h.

Treatment:

Procedure: Endoscopy exploration

Drug: Antibiotics (ceftazidime, cefotaxime, or meropenem, with or without vancomycin)

Dietary Supplement: Nutrition support

Commercial FG

Experimental group

Description:

Commercial FG (Zhejiang Puji Porcine fibrin sealant) was applied to close fistulas.

Treatment:

Procedure: Endoscopy exploration and glue application

Drug: Antibiotics (ceftazidime, cefotaxime, or meropenem, with or without vancomycin)

Dietary Supplement: Nutrition support