A Randomized Controlled Trial to Evaluate Fibrin Glue Application in the Treatment of Low-Output Enterocutaneous Fistulas
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
- Closure rates up to 14 days
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 enterocutaneous fistulas (ECFs). The primary objectives of this study are to compare the clinical efficacy, safety of autologous platelet-rich fibrin glue (PRFG), commercial fibrin glue, and control therapy in the management of patients with low-output volume ECFs.
详细描述
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This is a prospective, randomized, multi-centered study clinical, safety and economic outcome of ECFs patients.
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Subjects are randomized to one of 3 groups:
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Group 1: Autologous PRFG-treatment [PRFG + Standard of care (SOC)]
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Group 2: Commercial FG-treatment [FG + Standard of care (SOC)]
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Group 3: Control (SOC only)
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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, commercial FG, or SOC 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
Control
Patients in this group only received standard of care when their fistula output < 200ml/24h.
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 PRFG 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 PRFG 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: Antibiotics (ceftazidime, cefotaxime, or meropenem, with or without vancomycin) (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 PRFG 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)
Control
Patients in this group only received standard of care when their fistula output < 200ml/24h.
干预措施: Endoscopy exploration (Procedure)
Control
Patients in this group only received standard of care when their fistula output < 200ml/24h.
干预措施: Antibiotics (ceftazidime, cefotaxime, or meropenem, with or without vancomycin) (Drug)
Commercial FG
Commercial FG (Zhejiang Puji Porcine fibrin sealant) was applied to close fistulas.
干预措施: Endoscopy exploration and glue application (Procedure)
Commercial FG
Commercial FG (Zhejiang Puji Porcine fibrin sealant) was applied to close fistulas.
干预措施: Antibiotics (ceftazidime, cefotaxime, or meropenem, with or without vancomycin) (Drug)
Commercial FG
Commercial FG (Zhejiang Puji Porcine fibrin sealant) was applied to close fistulas.
干预措施: Nutrition support (Dietary Supplement)
结局指标
主要结局
Closure rates up to 14 days
时间窗: 14 days
The fraction of patients with complete closure of fistula during 14 days
次要结局
- Number of adverse events(Participants will be followed for at least 180 days)
研究者
Jianan Ren
Vice president of department of surgery, Jinling Hospital
Jinling Hospital, China