An interventional study of Endoscopy exploration and glue application and Anti-Bacterial Agents in Low-output External Gastrointestinal Fistula, sponsored by Jinling Hospital, China. Status unknown at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2014-03-11.
Sponsored by Jinling Hospital, China · Not applicable, Interventional, and Treatment
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.
Subjects are randomized to one of 2 groups:
Study will include three phases:
731 studies on the registry are indexed under Fistula; 103 are open to participants now.
This study's planned enrollment of 30 is below the median of 60 across 484 interventional studies indexed under Fistula.
Browse Fistula studies →Jinling Hospital, China is the lead sponsor of 126 studies on the registry; 34 are open to participants now.
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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.
Procedure: Endoscopy exploration and glue application · Drug: Anti-Bacterial Agents · Dietary Supplement: Nutrition support · Procedure: PRFG preparation
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.
Procedure: Endoscopy exploration and glue application · Drug: Anti-Bacterial Agents · Dietary Supplement: Nutrition support
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. Upon injection, two components, fibrinogen and thrombin, were mixed together in the mixing reservoir and yield a gelatin-like glue. This procedure was repeated in patients up to 3 times within 14-day FG treatment period.
Antibacterial therapy was given to patients with signs of systemic sepsis or local inflammation with pain.
Nutritional replacement and bowel rest via enteral or parenteral nutrition.
As described in our previous work, 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.
Clinical outcome
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
Time frame: 14 days
Safety outcome
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)
Time frame: up to 180 days
Economic outcome
Hospital cost upon enrollment; Hospital cost during entire hospital stay; Cost between fistula onset and final outcome
Time frame: Upon enrollment, an expected average of 1 year
This study is status unknown, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.
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Digestive System Fistula
Jinling Hospital, China