Glue Sealing for Patients With Low-Output ECFs (Glue-sealing)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Jinling Hospital, China
Sponsor:
Information provided by (Responsible Party):
Jianan Ren, Jinling Hospital, China
ClinicalTrials.gov Identifier:
NCT01672593
First received: August 19, 2012
Last updated: March 10, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Low-output External Gastrointestinal Fistula
Procedure: Endoscopy exploration and glue application
Drug: Anti-Bacterial Agents
Dietary Supplement: Nutrition support
Procedure: PRFG preparation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial to Evaluate Endoscopy Assisted Fibrin Glue Application in the Treatment of Low-Output ECFs

Resource links provided by NLM:


Further study details as provided by Jinling Hospital, China:

Primary Outcome Measures:
  • Clinical outcome [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Safety outcome [ Time Frame: up to 180 days ] [ Designated as safety issue: Yes ]
    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:
  • Economic outcome [ Time Frame: Upon enrollment, an expected average of 1 year ] [ Designated as safety issue: No ]
    Hospital cost upon enrollment; Hospital cost during entire hospital stay; Cost between fistula onset and final outcome


Estimated Enrollment: 30
Study Start Date: May 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 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.
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. 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.
Drug: Anti-Bacterial Agents
Antibacterial therapy was given to patients with signs of systemic sepsis or local inflammation with pain.
Dietary Supplement: Nutrition support
Nutritional replacement and bowel rest via enteral or parenteral nutrition.
Procedure: PRFG preparation
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.
Active Comparator: Bioseal treatment
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.
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. 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.
Drug: Anti-Bacterial Agents
Antibacterial therapy was given to patients with signs of systemic sepsis or local inflammation with pain.
Dietary Supplement: Nutrition support
Nutritional replacement and bowel rest via enteral or parenteral nutrition.

Detailed Description:
  • 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.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01672593

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

Locations
China, Jiangsu
Department of Surgery, Jinling Hospital Recruiting
Nanjing, Jiangsu, China, 210002
Contact: Jianan Ren, M.D.    862580860108    jiananr@gmail.com   
Sponsors and Collaborators
Jinling Hospital, China
  More Information

No publications provided

Responsible Party: Jianan Ren, Vice president of department of surgery, Jinling Hospital, Jinling Hospital, China
ClinicalTrials.gov Identifier: NCT01672593     History of Changes
Other Study ID Numbers: 20120818
Study First Received: August 19, 2012
Last Updated: March 10, 2014
Health Authority: China: Food and Drug Administration
United States: Food and Drug Administration

Keywords provided by Jinling Hospital, China:
Autologous platelet rich fibrin glue;
Enterocutaneous fistulas;
Single low output GI fistulas;

Additional relevant MeSH terms:
Fistula
Pathological Conditions, Anatomical
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014