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

A Randomized Controlled Trial to Evaluate Endoscopy Assisted Fibrin Glue Application in the Treatment of Low-Output ECFs

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.

Study Overview

• Status: Unknown
• Conditions: Low-output External Gastrointestinal Fistula
• Intervention / Treatment: Procedure: Endoscopy exploration and glue application; Drug: Anti-Bacterial Agents; Dietary supplement: Nutrition support; Procedure: PRFG preparation

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jianan Ren, MD; Phone Number: 862580860108; Email: Jiananr@gmail.com
• Study Contact Backup: Name: XIUWEN WU; Phone Number: 862580860008; Email: xiuwenwoo@gmail.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210002
      • Recruiting
      • Department of Surgery, Jinling Hospital
      • Contact: Jianan Ren, M.D.; Phone Number: 862580860108; Email: jiananr@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 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

How is the study designed?

Design Details

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

Number of Arms

2

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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical outcome	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	14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety outcome	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)	up to 180 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Economic outcome	Hospital cost upon enrollment; Hospital cost during entire hospital stay; Cost between fistula onset and final outcome	Upon enrollment, an expected average of 1 year

Collaborators and Investigators

• Sponsor: Jinling Hospital, China

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Anticipated): December 1, 2014
• Study Completion (Anticipated): December 1, 2014

Study Registration Dates

• First Submitted: August 19, 2012
• First Submitted That Met QC Criteria: August 22, 2012
• First Posted (Estimate): August 27, 2012

Study Record Updates

• Last Update Posted (Estimate): March 11, 2014
• Last Update Submitted That Met QC Criteria: March 10, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: Autologous platelet rich fibrin glue;; Enterocutaneous fistulas;; Single low output GI fistulas
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathological Conditions, Anatomical; Fistula; Digestive System Fistula; Anti-Infective Agents; Anti-Bacterial Agents
• Other Study ID Numbers: 20120818