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Glue Application in the Treatment of Low-Output Fistulas (FG-treatment)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01828892
Recruitment Status : Unknown
Verified June 2015 by Jianan Ren, Jinling Hospital, China.
Recruitment status was:  Recruiting
First Posted : April 11, 2013
Last Update Posted : June 10, 2015
Sponsor:
Information provided by (Responsible Party):
Jianan Ren, 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.

Condition or disease Intervention/treatment Phase
Low-output External Gastrointestinal Fistula Procedure: Endoscopy exploration and glue application Procedure: Endoscopy exploration Drug: Antibiotics (ceftazidime, cefotaxime, or meropenem, with or without vancomycin) Dietary Supplement: Nutrition support Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial to Evaluate Fibrin Glue Application in the Treatment of Low-Output Enterocutaneous Fistulas
Study Start Date : March 2014
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

Arm Intervention/treatment
Experimental: 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.
Procedure: 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.

Drug: Antibiotics (ceftazidime, cefotaxime, or meropenem, with or without vancomycin)
Antibacterial therapy in patients with signs of systemic sepsis or local inflammation with pain
Other Name: ceftazidime, cefotaxime, or meropenem, with or without vancomycin

Dietary Supplement: Nutrition support
Nutritional replacement and bowel rest via enteral or parenteral nutrition

Sham Comparator: Control
Patients in this group only received standard of care when their fistula output < 200ml/24h.
Procedure: 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.

Drug: Antibiotics (ceftazidime, cefotaxime, or meropenem, with or without vancomycin)
Antibacterial therapy in patients with signs of systemic sepsis or local inflammation with pain
Other Name: ceftazidime, cefotaxime, or meropenem, with or without vancomycin

Dietary Supplement: Nutrition support
Nutritional replacement and bowel rest via enteral or parenteral nutrition

Experimental: Commercial FG
Commercial FG (Zhejiang Puji Porcine fibrin sealant) was applied to close fistulas.
Procedure: 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.

Drug: Antibiotics (ceftazidime, cefotaxime, or meropenem, with or without vancomycin)
Antibacterial therapy in patients with signs of systemic sepsis or local inflammation with pain
Other Name: ceftazidime, cefotaxime, or meropenem, with or without vancomycin

Dietary Supplement: Nutrition support
Nutritional replacement and bowel rest via enteral or parenteral nutrition




Primary Outcome Measures :
  1. Closure rates up to 14 days [ Time Frame: 14 days ]
    The fraction of patients with complete closure of fistula during 14 days


Secondary Outcome Measures :
  1. Number of adverse events [ Time Frame: 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)


Other Outcome Measures:
  1. Economic outcome [ Time Frame: From fistula onset to the end of treatment, which is at least 180 days ]
    Hospital cost upon enrollment, Hospital cost during entire hospital stay, Cost between fistula onset and final outcome



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01828892


Contacts
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Contact: Jianan Ren, MD 862580860108 jiananr@gmail.com
Contact: XIUWEN WU 862580860008 xiuwenwoo@gmail.com

Locations
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China, Jiangsu
Jinling Hospital Recruiting
Nanjing, Jiangsu, China, 210002
Contact: Jianan Ren, MD    862580860108    Jiananr@gmail.com   
Sponsors and Collaborators
Jinling Hospital, China
Investigators
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Principal Investigator: Jianan Ren, MD Jinling Hospital, China
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jianan Ren, Vice president of department of surgery, Jinling Hospital, Jinling Hospital, China
ClinicalTrials.gov Identifier: NCT01828892    
Other Study ID Numbers: 20120819
First Posted: April 11, 2013    Key Record Dates
Last Update Posted: June 10, 2015
Last Verified: June 2015
Keywords provided by Jianan Ren, Jinling Hospital, China:
Autologous platelet rich fibrin glue
Enterocutaneous fistulas
Single low output GI fistulas
Additional relevant MeSH terms:
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Digestive System Fistula
Fistula
Pathological Conditions, Anatomical
Digestive System Diseases
Anti-Bacterial Agents
Vancomycin
Meropenem
Ceftazidime
Cefotaxime
Cefoxitin
Anti-Infective Agents