Low-output External Gastrointestinal Fistula
Conditions
Keywords
Autologous platelet rich fibrin glue;, Enterocutaneous fistulas;, Single low output GI fistulas;
Brief 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.
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.
Interventions
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.
DRUGAnti-Bacterial Agents
Antibacterial therapy was given to patients with signs of systemic sepsis or local inflammation with pain.
DIETARY_SUPPLEMENTNutrition support
Nutritional replacement and bowel rest via enteral or parenteral nutrition.
PROCEDUREPRFG 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.
Sponsors
Jinling Hospital, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical outcome | 14 days | 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
| Measure | Time frame | Description |
|---|---|---|
| Safety outcome | up to 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
| Measure | Time frame | Description |
|---|---|---|
| Economic outcome | Upon enrollment, an expected average of 1 year | Hospital cost upon enrollment; Hospital cost during entire hospital stay; Cost between fistula onset and final outcome |
Countries
China
Contacts
Primary ContactJianan Ren, MD
Backup ContactXIUWEN WU
Outcome results
None listed