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

• ClinicalTrials.gov Identifier: NCT01828892
• Recruitment Status: Unknown
• First Posted: April 11, 2013
• Last Update Posted: June 10, 2015
• Sponsor: Jinling Hospital, China
• Information provided by (Responsible Party): Jianan Ren, Jinling Hospital, China

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Contacts

Contact: Jianan Ren, MD; 862580860108; jiananr@gmail.com

Contact: XIUWEN WU; 862580860008; xiuwenwoo@gmail.com

Locations

China, Jiangsu

Jinling Hospital; Recruiting

Nanjing, Jiangsu, China, 210002

Contact: Jianan Ren, MD 862580860108 Jiananr@gmail.com

Sponsors and Collaborators

Jinling Hospital, China

Investigators

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Wu X, Ren J, Wang G, Wang J, Wang F, Fan Y, Li Y, Han G, Zhou Y, Song X, Quan B, Yao M, Li J. Evaluating the use of fibrin glue for sealing low-output enterocutaneous fistulas: study protocol for a randomized controlled trial. Trials. 2015 Oct 7;16:445. doi: 10.1186/s13063-015-0966-9.

• 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
• 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:

Digestive System Fistula; Fistula; Pathological Conditions, Anatomical; Digestive System Diseases; Anti-Bacterial Agents; Vancomycin; Meropenem; Ceftazidime; Cefotaxime; Cefoxitin; Anti-Infective Agents