Glue Application in the Treatment of Low-Output Fistulas

Low-output External Gastrointestinal Fistula Clinical Trial

— FG-treatment  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01828892
• Other study ID #: 20120819
• Status: Recruiting
• Phase: N/A
• First received: April 1, 2013
• Last updated: June 9, 2015
• Start date: March 2014
• Est. completion date: December 2017

Study information

• Verified date: June 2015
• Source: Jinling Hospital, China
• Contact: Jianan Ren, MD
• Phone: 862580860108
• Email: jiananr[@]gmail.com
• Is FDA regulated: No
• Health authority: China: Food and Drug AdministrationUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Digestive System Fistula
• Fistula
• Low-output External Gastrointestinal Fistula

Intervention

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.
• 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

Dietary Supplement:
• Nutrition support
Nutritional replacement and bowel rest via enteral or parenteral nutrition

Locations

Country	Name	City	State
China	Jinling Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Jinling Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Economic outcome	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	No
Primary	Closure rates up to 14 days	The fraction of patients with complete closure of fistula during 14 days	14 days	No
Secondary	Number of adverse events	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	Yes