<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01672593</url>
  </required_header>
  <id_info>
    <org_study_id>20120818</org_study_id>
    <nct_id>NCT01672593</nct_id>
  </id_info>
  <brief_title>Glue Sealing for Patients With Low-Output ECFs</brief_title>
  <acronym>Glue-sealing</acronym>
  <official_title>A Randomized Controlled Trial to Evaluate Endoscopy Assisted Fibrin Glue Application in the Treatment of Low-Output ECFs</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jinling Hospital, China</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jinling Hospital, China</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Adjuvant use of fibrin glue (FG) in the fistula tract has been shown to promote closure of&#xD;
      low-output ECFs. The primary objectives of this study are to compare the clinical efficacy,&#xD;
      safety of autologous platelet-rich fibrin glue (PRFG) and a commercially available fibrin&#xD;
      sealant Bioseal® in the management of patients with low-output volume ECFs.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      -  This is a prospective, randomized, single-centered study clinical, safety and economic&#xD;
           outcome of ECFs patients.&#xD;
&#xD;
        -  Subjects are randomized to one of 2 groups:&#xD;
&#xD;
             -  Group 1: Autologous PRFG-treatment (PRFG + SOC)&#xD;
&#xD;
             -  Group 2: Commercial FG-treatment (Bioseal® + SOC)&#xD;
&#xD;
        -  Study will include three phases:&#xD;
&#xD;
             -  Phase 1: Screening, consent and enrollment&#xD;
&#xD;
             -  Phase 2: Patients will receive either PRFG, or Bioseal only for 14 days&#xD;
&#xD;
             -  Phase 3: Follow up: for patients with closed fistula within 14 days, we will follow&#xD;
                up them for 6 months. For patients whose fistulas were still open will be treated&#xD;
                with other therapeutic option and follow up for 6 months after closure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>May 2012</start_date>
  <completion_date type="Anticipated">December 2014</completion_date>
  <primary_completion_date type="Anticipated">December 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical outcome</measure>
    <time_frame>14 days</time_frame>
    <description>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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety outcome</measure>
    <time_frame>up to 180 days</time_frame>
    <description>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)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Economic outcome</measure>
    <time_frame>Upon enrollment, an expected average of 1 year</time_frame>
    <description>Hospital cost upon enrollment; Hospital cost during entire hospital stay; Cost between fistula onset and final outcome</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Low-output External Gastrointestinal Fistula</condition>
  <arm_group>
    <arm_group_label>PRFG treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bioseal treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Endoscopy exploration and glue application</intervention_name>
    <description>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.</description>
    <arm_group_label>Bioseal treatment</arm_group_label>
    <arm_group_label>PRFG treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Anti-Bacterial Agents</intervention_name>
    <description>Antibacterial therapy was given to patients with signs of systemic sepsis or local inflammation with pain.</description>
    <arm_group_label>Bioseal treatment</arm_group_label>
    <arm_group_label>PRFG treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Nutrition support</intervention_name>
    <description>Nutritional replacement and bowel rest via enteral or parenteral nutrition.</description>
    <arm_group_label>Bioseal treatment</arm_group_label>
    <arm_group_label>PRFG treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>PRFG preparation</intervention_name>
    <description>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.</description>
    <arm_group_label>PRFG treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with a single tubular ECF&#xD;
&#xD;
          -  Low output volume (&lt;200 ml/24h)&#xD;
&#xD;
          -  Tract length &gt;2cm&#xD;
&#xD;
          -  Tract diameter &lt; 1cm&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cancer-infiltrated fistula&#xD;
&#xD;
          -  Abscess&#xD;
&#xD;
          -  Foreign bodies&#xD;
&#xD;
          -  Distal bowel obstruction&#xD;
&#xD;
          -  Inflammatory bowel disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Jianan Ren, MD</last_name>
    <phone>862580860108</phone>
    <email>jiananr@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>XIUWEN WU</last_name>
    <phone>862580860008</phone>
    <email>xiuwenwoo@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Department of Surgery, Jinling Hospital</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210002</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jianan Ren, M.D.</last_name>
      <phone>862580860108</phone>
      <email>jiananr@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2014</verification_date>
  <study_first_submitted>August 19, 2012</study_first_submitted>
  <study_first_submitted_qc>August 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2012</study_first_posted>
  <last_update_submitted>March 10, 2014</last_update_submitted>
  <last_update_submitted_qc>March 10, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 11, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Jinling Hospital, China</investigator_affiliation>
    <investigator_full_name>Jianan Ren</investigator_full_name>
    <investigator_title>Vice president of department of surgery, Jinling Hospital</investigator_title>
  </responsible_party>
  <keyword>Autologous platelet rich fibrin glue;</keyword>
  <keyword>Enterocutaneous fistulas;</keyword>
  <keyword>Single low output GI fistulas;</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Digestive System Fistula</mesh_term>
    <mesh_term>Fistula</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anti-Bacterial Agents</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01672593
org study id: 20120818
nct id: NCT01672593
lead sponsor: 
has dmc: Yes
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.
-  This is a prospective, randomized, single-centered study clinical, safety and economic
           outcome of ECFs patients.

        -  Subjects are randomized to one of 2 groups:

             -  Group 1: Autologous PRFG-treatment (PRFG + SOC)

             -  Group 2: Commercial FG-treatment (Bioseal® + SOC)

        -  Study will include three phases:

             -  Phase 1: Screening, consent and enrollment

             -  Phase 2: Patients will receive either PRFG, or Bioseal 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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Clinical outcome
time frame: 14 days
description: 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
measure: Safety outcome
time frame: up to 180 days
description: 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)
measure: Economic outcome
time frame: Upon enrollment, an expected average of 1 year
description: Hospital cost upon enrollment; Hospital cost during entire hospital stay; Cost between fistula onset and final outcome
arm group label: PRFG treatment
arm group type: Experimental
description: 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.
arm group label: Bioseal treatment
arm group type: Active Comparator
description: 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.
intervention type: Procedure
intervention name: Endoscopy exploration and glue application
description: 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.
arm group label: Bioseal treatment
arm group label: PRFG treatment
intervention type: Drug
intervention name: Anti-Bacterial Agents
description: Antibacterial therapy was given to patients with signs of systemic sepsis or local inflammation with pain.
arm group label: Bioseal treatment
arm group label: PRFG treatment
intervention type: Dietary Supplement
intervention name: Nutrition support
description: Nutritional replacement and bowel rest via enteral or parenteral nutrition.
arm group label: Bioseal treatment
arm group label: PRFG treatment
intervention type: Procedure
intervention name: PRFG preparation
description: 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.
arm group label: PRFG treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Jianan Ren, MD
phone: 862580860108
email: jiananr@gmail.com
last name: XIUWEN WU
phone: 862580860008
email: xiuwenwoo@gmail.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Jinling Hospital, China
investigator full name: Jianan Ren
investigator title: Vice president of department of surgery, Jinling Hospital
mesh term: Digestive System Fistula
mesh term: Fistula
mesh term: Anti-Bacterial Agents