This study is to assess whether utilizing endoscopic ultrasound(EUS) to guide treatment can improve durable fistula healing in patients with Crohn's perianal fistulas and to get preliminary information regarding the effectiveness of Adalimumab for Crohn's perianal fistulas.
Prospective randomized trial to assess the effectiveness of rectal EUS to guide perianal fistula treatment. Our hypothesis is that using imaging, in this case endoscopic ultrasound (EUS), to initially evaluate and then guide therapy with an anti-TNF agent (adalimumab) for fistulizing disease will lead to better short- and long-term outcomes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
21
Patients randomized to the combination therapy group, the surgeon will have access to EUS findings.
Patients began therapy with adalimumab using clinic standards for dosing.
Patients in combination therapy group had an EUS done every 12 weeks to help guide therapy.
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Number of Participants With Durable Fistula Healing
Complete cessation of fistula drainage at 48 weeks
Time frame: at week 48
Changes in Disease Activity
Changes in Crohn's disease activity using the Harvey Bradshaw Index (HBI) at Week 48 compared to baseline HBI Scores. Higher numbers for the HBI equal more significant disease activity. Range can vary from 0 to 17 plus the number of liquid stools per day.
Time frame: Baseline and 48 Weeks
Changes in Perianal Disease Activity Index (PDAI)
Changes in Crohn's disease activity at Week 48 compared to baseline based on PDAI Scores- higher numbers equal more significant disease activity. PDAI has a range from 0 to 20.
Time frame: Baseline and 48 Weeks
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