Emerging treatments for complex perianal fistula in Crohn’s disease

Table 1 Summary of studies of local treatments

Intervention reference	Study design and patients	Main findings
Topical tacrolimus
Casson et al[63], 2000	Case study of series of pediatric Crohn’s patients including 1 patient with perianal fistula	Response reported in patient with perianal fistula
Hart et al[64], 2007	Randomized, placebo-controlled study in 19 patients (12 Crohn’s)	Treatment found not to be beneficial in perianal fistulas
Fibrin glue
Abel et al[79], 1993	Uncontrolled study of use of fibrin glue in 10 patients (2 Crohn’s)	0/2 patients with Crohn’s disease achieved healing
Cintron et al[80], 2000	79 patients (6 Crohn’s) assigned to 3 types of fibrin glue treatment	2/6 Crohn’s patients (33%) achieved healing (no drainage)
Lindsey et al[66], 2002	Randomized trial comparing fibrin glue with conventional surgery (fistulotomy or loose seton placement) in 42 patients (6 Crohn’s and complex perianal fistula)	Healing (no drainage) in 2/6 Crohn’s patients (33%) who received fibrin glue. No Crohn’s patients received conventional surgery
Sentovich[81], 2003	Uncontrolled study: 48 patients (5 Crohn’s) underwent seton placement followed by instillation of fibrin glue	Healing in 4/5 (80%) Crohn’s patients
Zmora et al[82], 2003	Retrospective review of 37 patients with perineal fistula (7 Crohn’s) treated with fibrin glue	Healing in 3/7 Crohn’s patients (43%) (2 patients also treated with endorectal advancement flap)
Loungnarath et al[83], 2004	Retrospective review of 42 patients with perianal fistula (13 Crohn’s) treated with fibrin glue	Lasting fistula healing in 4/13 (31%)
Singer et al[84], 2005	Randomized trial comparing fibrin glue + antibiotics, fibrin glue + surgery, and fibrin glue + antibiotic and surgery in 75 patients (3 Crohn’s)	Treatment failed in all 3 Crohn’s patients (fibrin glue + antibiotic in 1 patient and fibrin + antibiotic and surgery in 2 patients)
Intralesional infliximab
Poggioli et al[68], 2005	Uncontrolled study of 15 Crohn’s patients with complex perianal fistulas	Healing in 10/15 patients after 3-12 infusions
Asteria et al[69], 2006	Uncontrolled study of 11 Crohn’s patients with complex perianal fistulas naïve to infliximab	8/11 patients responded (≥ 50% reduction in fistula drainage) to treatment
Adipose-derived stem cell (ASC) therapy with fibrin glue
García-Olmo et al[72], 2005	Uncontrolled proof-of-concept study in patients with fistulizing Crohn’s disease, including 1 perineal fistula	Perineal fistula healed after 8 wk
Garcia-Olmo et al[73], 2009	Randomized controlled phase II study comparing fibrin glue + ASCs with fibrin glue in 49 patients with complex perianal fistula (14 Crohn’s)	Healing in 5/7 Crohn’s patients (71%) in fibrin glue + ASCs group compared to 1/7 (14%) in the control group
Fistula plugs
O’Connor et al[75], 2006	Uncontrolled study of fistula plug in 20 Crohn’s patients with fistula tracts not amenable to fistulotomy	Success rate of 80%, lower in the case of complex fistulas
Schwandner et al[76], 2008	Uncontrolled study of 19 patients (7 Crohn’s) with transsphincteric anorectal fistulas	Treatment success in 6/7 patients with Crohn’s disease (86%)
Ky et al[77], 2008	Prospective analysis of 45 patients (20 with complex fistulas and 14 with Crohn’s disease) receiving anal fistula plug	Healing in 4/14 Crohn’s patients (29%) after a median follow-up of 6.5 mo