Glue Sealing for Patients With Low-Output ECFs

Not Applicable

• Conditions: Low-output External Gastrointestinal Fistula
• Interventions: Procedure: Endoscopy exploration and glue application; Drug: Anti-Bacterial Agents; Dietary Supplement: Nutrition support; Procedure: PRFG preparation

• Registration Number: NCT01672593
• Lead Sponsor: Jinling Hospital, China

Brief 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.

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-08-19
• Study First Submitted QC: 2012-08-22
• Study First Posted: 2012-08-27
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-10
• Last Update Posted: 2014-03-11
• Primary Completion: 2014-12
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PRFG treatment	Endoscopy exploration and glue application	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.
PRFG treatment	Anti-Bacterial Agents	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.
PRFG treatment	Nutrition support	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.
PRFG treatment	PRFG preparation	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.
Bioseal treatment	Anti-Bacterial Agents	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.
Bioseal treatment	Endoscopy exploration and glue application	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.
Bioseal treatment	Nutrition support	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.

Primary Outcome Measures

Name	Time	Method
Clinical outcome	14 days	Closure time (defined as the interval between the day of enrollment and day of fistula closure), Closure rate up to 14 days, Closure rate up to 180 days, Fistula recurrence rate

Secondary Outcome Measures

Name	Time	Method
Safety outcome	up to 180 days	Incidence of adverse events and severe adverse events up to 180 days (defined as an event that was fatal or life-threatening, led to additional hospitalization or disability, or required an intervention to prevent one of these outcomes)

Trial Locations

Locations (1)

Department of Surgery, Jinling Hospital; 🇨🇳 Nanjing, Jiangsu, China