Glue Sealing for Patients With Low-Output ECFs (Glue-sealing)

Jinling Hospital, China

Status: Unknown

Conditions: Low-output External Gastrointestinal Fistula

Treatments: Drug: Anti-Bacterial Agents; Dietary Supplement: Nutrition support; Procedure: Endoscopy exploration and glue application; Procedure: PRFG preparation

Study type: Interventional

Funder types: Other

Identifiers

NCT01672593

20120818

Details and patient eligibility

About

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.

Full description

• 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.

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 2 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 autologous PRFG(platelet-rich fibrin glue) 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: PRFG preparation

Drug: Anti-Bacterial Agents

Procedure: Endoscopy exploration and glue application

Dietary Supplement: Nutrition support

Bioseal treatment

Active Comparator group

Description:

The commercial fibrin sealants used in the study were purchased from Guangzhou Bioseal Biotech Co. Ltd, Guangzhou, China. Upon application, two components, fibrinogen and thrombin, were placed separately in two syringes which were joined by a Y-shaped connector. The trunk of the Y-shaped connecter was connected to a single lumen catheter.

Treatment:

Drug: Anti-Bacterial Agents

Procedure: Endoscopy exploration and glue application

Dietary Supplement: Nutrition support