Glue Sealing for Patients With Low-Output ECFs

Low-output External Gastrointestinal Fistula Clinical Trial

— Glue-sealing  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01672593
• Other study ID #: 20120818
• Status: Recruiting
• Phase: N/A
• First received: August 19, 2012
• Last updated: March 10, 2014
• Start date: May 2012
• Est. completion date: December 2014

Study information

• Verified date: March 2014
• 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• 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. 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.

Locations

Country	Name	City	State
China	Department of Surgery, 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	Upon enrollment, an expected average of 1 year	No
Primary	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	No
Secondary	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	Yes