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

June 9, 2015 updated by: Jianan Ren, Jinling Hospital, China

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210002
        • Recruiting
        • Jinling Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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 Names:
  • 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.
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 Names:
  • ceftazidime, cefotaxime, or meropenem, with or without vancomycin
Dietary supplement: Nutrition support
Nutritional replacement and bowel rest via enteral or parenteral nutrition
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.
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 Names:
  • ceftazidime, cefotaxime, or meropenem, with or without vancomycin
Dietary supplement: Nutrition support
Nutritional replacement and bowel rest via enteral or parenteral nutrition

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Closure rates up to 14 days
Time Frame: 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
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)
Participants will be followed for at least 180 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From fistula onset to the end of treatment, which is at least 180 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jinling Hospital, China

Investigators

  • Principal Investigator: Jianan Ren, MD, Jinling Hospital, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Anticipated)

June 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

April 1, 2013

First Submitted That Met QC Criteria

April 10, 2013

First Posted (Estimate)

April 11, 2013

Study Record Updates

Last Update Posted (Estimate)

June 10, 2015

Last Update Submitted That Met QC Criteria

June 9, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20120819

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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