A Randomized Controlled Trial to Evaluate Endoscopy Assisted Fibrin Glue Application in the Treatment of Low-Output ECFs
Overview
- Phase
- Not Applicable
- Intervention
- Endoscopy exploration and glue application
- Conditions
- Low-output External Gastrointestinal Fistula
- Sponsor
- Jinling Hospital, China
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Clinical outcome
- Last Updated
- 12 years ago
Overview
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.
Investigators
Jianan Ren
Vice president of department of surgery, Jinling Hospital
Jinling Hospital, China
Eligibility Criteria
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
- •Foreign bodies
- •Distal bowel obstruction
- •Inflammatory bowel disease
Arms & Interventions
PRFG treatment
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.
Intervention: Endoscopy exploration and glue application
PRFG treatment
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.
Intervention: Anti-Bacterial Agents
PRFG treatment
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.
Intervention: Nutrition support
PRFG treatment
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.
Intervention: PRFG preparation
Bioseal treatment
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.
Intervention: Endoscopy exploration and glue application
Bioseal treatment
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.
Intervention: Anti-Bacterial Agents
Bioseal treatment
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.
Intervention: Nutrition support
Outcomes
Primary Outcomes
Clinical outcome
Time Frame: 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 Outcomes
- Safety outcome(up to 180 days)