Glue Application in the Treatment of Low-Output Fistulas
NCT ID: NCT01828892
Last Updated: 2015-06-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2014-03-31
2017-12-31
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Endoscopy exploration and glue application
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.
Antibiotics (ceftazidime, cefotaxime, or meropenem, with or without vancomycin)
Antibacterial therapy in patients with signs of systemic sepsis or local inflammation with pain
Nutrition support
Nutritional replacement and bowel rest via enteral or parenteral nutrition
Control
Patients in this group only received standard of care when their fistula output \< 200ml/24h.
Endoscopy exploration
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.
Antibiotics (ceftazidime, cefotaxime, or meropenem, with or without vancomycin)
Antibacterial therapy in patients with signs of systemic sepsis or local inflammation with pain
Nutrition support
Nutritional replacement and bowel rest via enteral or parenteral nutrition
Commercial FG
Commercial FG (Zhejiang Puji Porcine fibrin sealant) was applied to close fistulas.
Endoscopy exploration and glue application
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.
Antibiotics (ceftazidime, cefotaxime, or meropenem, with or without vancomycin)
Antibacterial therapy in patients with signs of systemic sepsis or local inflammation with pain
Nutrition support
Nutritional replacement and bowel rest via enteral or parenteral nutrition
Interventions
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Endoscopy exploration and glue application
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.
Endoscopy exploration
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.
Antibiotics (ceftazidime, cefotaxime, or meropenem, with or without vancomycin)
Antibacterial therapy in patients with signs of systemic sepsis or local inflammation with pain
Nutrition support
Nutritional replacement and bowel rest via enteral or parenteral nutrition
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Low output volume (\<200 ml/24h)
* Tract length \>2cm
* Tract diameter \< 1cm
Exclusion Criteria
* Abscess
* Foreign bodies
* Distal bowel obstruction
* Inflammatory Bowel Disease
18 Years
65 Years
ALL
No
Sponsors
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Jinling Hospital, China
OTHER
Responsible Party
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Jianan Ren
Vice president of department of surgery, Jinling Hospital
Principal Investigators
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Jianan Ren, MD
Role: PRINCIPAL_INVESTIGATOR
Jinling Hospital, China
Locations
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Jinling Hospital
Nanjing, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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References
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Wu X, Ren J, Wang G, Wang J, Wang F, Fan Y, Li Y, Han G, Zhou Y, Song X, Quan B, Yao M, Li J. Evaluating the use of fibrin glue for sealing low-output enterocutaneous fistulas: study protocol for a randomized controlled trial. Trials. 2015 Oct 7;16:445. doi: 10.1186/s13063-015-0966-9.
Other Identifiers
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20120819
Identifier Type: -
Identifier Source: org_study_id
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