title: A randomized prospective trial of endoscopic ultrasound to guide combination medical and surgical treatment for Crohn's perianal fistulas.
abstract: OBJECTIVE
  To prospectively determine if rectal endoscopic ultrasound (EUS) can guide combination medical and surgical therapy and improve outcomes for patients with perianal fistulizing Crohn's disease.
  
  
  METHODS
  Ten patients with perianal Crohn's disease were prospectively enrolled in a randomized prospective pilot study. The patients were randomized to either the EUS cohort or the control group. All patients underwent a rectal EUS to delineate fistula anatomy followed by an examination under anesthesia by a colorectal surgeon with seton placement and/or incision and drainage, as indicated. The surgeon was blinded to the initial EUS results of patients in the control group. Medical treatment was maximized with 6-mercaptopurine (1.0-1.5 mg/kg) or azathioprine (2.0-2.5 mg/kg), ciprofloxacin (1,000 mg a day) or metronidazole (1,500 mg a day), and infliximab (5 mg/kg at 0, 2, and 6 wk and then every 8 wk). For patients in the control group, additional interventions (seton removal and repeat surgery) were at the discretion of the surgeon (without EUS guidance). Patients in the EUS cohort had EUS performed at weeks 22 and 38, with additional surgical interventions based on EUS findings. The primary end point was complete cessation of drainage at week 54. All patients had a repeat EUS performed at week 54 to determine the fistula status on EUS (secondary end point). The need for additional surgery was defined as a treatment failure.
  
  
  RESULTS
  Ten patients were enrolled in the study. One of 5 (20%) in the control group and 4 of 5 (80%) in the EUS group had complete cessation of drainage. From the control group, 3 patients failed due to repeat surgery (2 for persistent/recurrent fistula and 1 for abscess), and 1 had a persistent drainage at week 54. In the EUS cohort, 1 patient had a recurrent abscess after his seton fell out prematurely. In the EUS cohort, the median time to cessation of drainage was 99 days, and the time to EUS evidence of fistula inactivity was 229 days.
  
  
  CONCLUSIONS
  This pilot study suggests that using EUS to guide combination medical and surgical therapy for perianal fistulizing Crohn's disease improves the outcomes.
authors.affiliation: Inflammatory Bowel Disease Center, Vanderbilt University Medical Center, Nashville, Tennessee 37232, USA.
authors.forename: Natalie M
authors.initials: NM
authors.lastname: Spradlin
authors.forename: Paul E
authors.initials: PE
authors.lastname: Wise
authors.forename: Alan J
authors.initials: AJ
authors.lastname: Herline
authors.forename: Roberta L
authors.initials: RL
authors.lastname: Muldoon
authors.forename: Michael
authors.initials: M
authors.lastname: Rosen
authors.forename: David A
authors.initials: DA
authors.lastname: Schwartz
mesh_terms: D000328:Adult; D000368:Aged; D003424:Crohn Disease / Q000150:complications* / Q000000981:diagnostic imaging; D004322:Drainage / Q000379:methods; D004359:Drug Therapy, Combination; D019160:Endosonography / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D005765:Gastrointestinal Agents / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012003:Rectal Fistula / Q000000981:diagnostic imaging* / Q000209:etiology / Q000628:therapy*; D012720:Severity of Illness Index; D016896:Treatment Outcome; D014945:Wound Healing / Q000502:physiology
chemical_list: D005765:Gastrointestinal Agents