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

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

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.

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.

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.

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.

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.

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)

Hospital cost upon enrollment, Hospital cost during entire hospital stay, Cost between fistula onset and final outcome

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

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.