NCT01672593

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Jinling Hospital, China · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Low-output External Gastrointestinal Fistula

Interventions

Type	Name	Description
PROCEDURE	Endoscopy exploration and glue application	A forward-viewing fistula-fiberscope (EndoView, Outai Medical Equipment, Shanghai, China), with 15cm length and 5mm width of fiber optical wire, was inserted into the fistula tract to accomplish endoscopic visualization. Briefly, the fistula-fiberscope assisted procedure was carried out percutaneously, allowing the exposure of internal hole and the whole tracts, followed by insertion of this catheter with distal mixing device. Upon injection, two components, fibrinogen and thrombin, were mixed together in the mixing reservoir and yield a gelatin-like glue. This procedure was repeated in patients up to 3 times within 14-day FG treatment period.
DRUG	Anti-Bacterial Agents	Antibacterial therapy was given to patients with signs of systemic sepsis or local inflammation with pain.
DIETARY_SUPPLEMENT	Nutrition support	Nutritional replacement and bowel rest via enteral or parenteral nutrition.
PROCEDURE	PRFG preparation	As described in our previous work, 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.

Timeline

• Start date: 2012-05-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2012-08-27
• Last updated: 2014-03-11

Locations

1 site across 1 country: China