An interventional study of Endoscopy exploration and glue application and Endoscopy exploration 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 2015-06-10.
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 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.
Subjects are randomized to one of 3 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.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 · Drug: Antibiotics (ceftazidime, cefotaxime, or meropenem, with or without vancomycin) · Dietary Supplement: Nutrition support
Patients in this group only received standard of care when their fistula output \< 200ml/24h.
Procedure: Endoscopy exploration · Drug: Antibiotics (ceftazidime, cefotaxime, or meropenem, with or without vancomycin) · Dietary Supplement: Nutrition support
Commercial FG (Zhejiang Puji Porcine fibrin sealant) was applied to close fistulas.
Procedure: Endoscopy exploration and glue application · Drug: Antibiotics (ceftazidime, cefotaxime, or meropenem, with or without vancomycin) · 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.
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.
Antibacterial therapy in patients with signs of systemic sepsis or local inflammation with pain
Also known as: ceftazidime, cefotaxime, or meropenem, with or without vancomycin
Nutritional replacement and bowel rest via enteral or parenteral nutrition
Closure rates up to 14 days
The fraction of patients with complete closure of fistula during 14 days
Time frame: 14 days
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)
Time frame: Participants will be followed for at least 180 days
Economic outcome
Hospital cost upon enrollment, Hospital cost during entire hospital stay, Cost between fistula onset and final outcome
Time frame: From fistula onset to the end of treatment, which is at least 180 days
This study is status unknown, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.
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Digestive System Fistula
Jinling Hospital, China