Glue Application in the Treatment of Low-Output Fistulas
- Conditions
- Low-output External Gastrointestinal Fistula
- Interventions
- Procedure: Endoscopy exploration and glue applicationProcedure: Endoscopy explorationDrug: Antibiotics (ceftazidime, cefotaxime, or meropenem, with or without vancomycin)Dietary Supplement: Nutrition support
- Registration Number
- NCT01828892
- 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 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.
- Detailed Description
* This is a prospective, randomized, multi-centered study clinical, safety and economic outcome of ECFs patients.
* Subjects are randomized to one of 3 groups:
* Group 1: Autologous PRFG-treatment \[PRFG + Standard of care (SOC)\]
* Group 2: Commercial FG-treatment \[FG + Standard of care (SOC)\]
* Group 3: Control (SOC only)
* Study will include three phases:
* Phase 1: Screening, consent and enrollment
* Phase 2: Patients will receive either PRFG, commercial FG, or SOC 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
- Patients with a single tubular ECF
- Low output volume (<200 ml/24h)
- Tract length >2cm
- Tract diameter < 1cm
- 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 Commercial FG Endoscopy exploration and glue application Commercial FG (Zhejiang Puji Porcine fibrin sealant) was applied to close fistulas. PRFG treatment Antibiotics (ceftazidime, cefotaxime, or meropenem, with or without vancomycin) 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. Control Endoscopy exploration Patients in this group only received standard of care when their fistula output \< 200ml/24h. 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 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. Control Nutrition support Patients in this group only received standard of care when their fistula output \< 200ml/24h. Commercial FG Antibiotics (ceftazidime, cefotaxime, or meropenem, with or without vancomycin) Commercial FG (Zhejiang Puji Porcine fibrin sealant) was applied to close fistulas. Commercial FG Nutrition support Commercial FG (Zhejiang Puji Porcine fibrin sealant) was applied to close fistulas. 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 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. Control Antibiotics (ceftazidime, cefotaxime, or meropenem, with or without vancomycin) Patients in this group only received standard of care when their fistula output \< 200ml/24h.
- Primary Outcome Measures
Name Time Method Closure rates up to 14 days 14 days The fraction of patients with complete closure of fistula during 14 days
- Secondary Outcome Measures
Name Time Method Number of adverse events Participants will be followed for at least 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)
Jinling Hospital
🇨🇳Nanjing, Jiangsu, China