A Randomized Controlled Trial to Evaluate Endoscopy Assisted Fibrin Glue Application in the Treatment of Low-Output ECFs
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Clinical outcome
研究概览
简要总结
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.
详细描述
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This is a prospective, randomized, single-centered study clinical, safety and economic outcome of ECFs patients.
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Subjects are randomized to one of 2 groups:
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Group 1: Autologous PRFG-treatment (PRFG + SOC)
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Group 2: Commercial FG-treatment (Bioseal® + SOC)
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Study will include three phases:
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Phase 1: Screening, consent and enrollment
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Phase 2: Patients will receive either PRFG, or Bioseal only for 14 days
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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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a single tubular ECF
- •Low output volume (<200 ml/24h)
- •Tract length >2cm
- •Tract diameter < 1cm
排除标准
- •Cancer-infiltrated fistula
- •Foreign bodies
- •Distal bowel obstruction
- •Inflammatory bowel disease
研究组 & 干预措施
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.
干预措施: Endoscopy exploration and glue application (Procedure)
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.
干预措施: Anti-Bacterial Agents (Drug)
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.
干预措施: Nutrition support (Dietary Supplement)
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.
干预措施: PRFG preparation (Procedure)
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.
干预措施: Endoscopy exploration and glue application (Procedure)
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.
干预措施: Anti-Bacterial Agents (Drug)
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.
干预措施: Nutrition support (Dietary Supplement)
结局指标
主要结局
Clinical outcome
时间窗: 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
次要结局
- Safety outcome(up to 180 days)
研究者
Jianan Ren
Vice president of department of surgery, Jinling Hospital
Jinling Hospital, China