Glue Application in the Treatment of Low-Output Fistulas

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized Controlled Trial to Evaluate Fibrin Glue Application in the Treatment of Low-Output Enterocutaneous Fistulas

Conditions
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Low-output External Gastrointestinal Fistula

Intervention / Treatment
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* Procedure: Endoscopy exploration and glue application
* Procedure: Endoscopy exploration
* Drug: Antibiotics (ceftazidime, cefotaxime, or meropenem, with or without vancomycin)
* Dietary Supplement: Nutrition support


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRFG treatment<br>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. | Procedure: Endoscopy exploration and glue application<br>* A forward-viewing fistula-fiberscope (EndoView, Outai Medical Equipment, Shanghai, China), with 15cm length and 5mm width of fiber optical wire, was inserted into the fistula tract to accomplish endoscopic visualization. Briefly, the fistula-fiberscope assisted procedure was carried out percutaneously, allowing the exposure of internal hole and the whole tracts, followed by insertion of this catheter with distal mixing device.<br>Drug: Antibiotics (ceftazidime, cefotaxime, or meropenem, with or without vancomycin)<br>* Antibacterial therapy in patients with signs of systemic sepsis or local inflammation with pain<br>* Other names: ceftazidime, cefotaxime, or meropenem, with or without vancomycin;Dietary Supplement: Nutrition support<br>* Nutritional replacement and bowel rest via enteral or parenteral nutrition<br>|
| Sham Comparator: Control<br>Patients in this group only received standard of care when their fistula output < 200ml/24h. | Procedure: Endoscopy exploration<br>* A forward-viewing fistula-fiberscope (EndoView, Outai Medical Equipment, Shanghai, China), with 15cm length and 5mm width of fiber optical wire, was inserted into the fistula tract to accomplish endoscopic visualization.<br>Drug: Antibiotics (ceftazidime, cefotaxime, or meropenem, with or without vancomycin)<br>* Antibacterial therapy in patients with signs of systemic sepsis or local inflammation with pain<br>* Other names: ceftazidime, cefotaxime, or meropenem, with or without vancomycin;Dietary Supplement: Nutrition support<br>* Nutritional replacement and bowel rest via enteral or parenteral nutrition<br>|
| Experimental: Commercial FG<br>Commercial FG (Zhejiang Puji Porcine fibrin sealant) was applied to close fistulas. | Procedure: Endoscopy exploration and glue application<br>* A forward-viewing fistula-fiberscope (EndoView, Outai Medical Equipment, Shanghai, China), with 15cm length and 5mm width of fiber optical wire, was inserted into the fistula tract to accomplish endoscopic visualization. Briefly, the fistula-fiberscope assisted procedure was carried out percutaneously, allowing the exposure of internal hole and the whole tracts, followed by insertion of this catheter with distal mixing device.<br>Drug: Antibiotics (ceftazidime, cefotaxime, or meropenem, with or without vancomycin)<br>* Antibacterial therapy in patients with signs of systemic sepsis or local inflammation with pain<br>* Other names: ceftazidime, cefotaxime, or meropenem, with or without vancomycin;Dietary Supplement: Nutrition support<br>* Nutritional replacement and bowel rest via enteral or parenteral nutrition<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Closure rates up to 14 days | The fraction of patients with complete closure of fistula during 14 days | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events | 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) | Participants will be followed for at least 180 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Autologous platelet rich fibrin glue, Enterocutaneous fistulas, Single low output GI fistulas