ENDO ACE TRIALEndoscopic Balloon Dilatation of stenotic ileocecal anastomosis in Crohn´s disease with or without additive local steroid injection and oral Budenofalk;a randomized controlled trial - ENDO ACE TRIA

niversity Medical Center Utrecht0 个研究点目标入组 42 人开始时间: 2008年9月18日最近更新: 2013年12月23日

适应症

试验速览

暂无简介。

•Informed consent
•Man or woman between 18 and 75 years of age
•Established diagnosis of Crohn’s disease
•Negative stool culture (for exclusion of infectious ileocolitis and Clostridium Difficile infection)
•History of ileocecal resection
•= 2 symptoms of intestinal obstruction
•-Intermittent abdominal pain
•-Abdominal distension
•Significant stenotic segment (defined as a decrease in calibre of the intestinal lumen with or without a pre-stenotic dilatation) located at the anastomosis as diagnosed with MR enterography and abdominal ultrasound.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•A stenotic segment of more than 5 cm
•Rutgeerts score i4 inflammation at the site of stenosis
•Fistulas at the site of stenosis or in the near proximity
•A stenosis that cannot be properly endoscopically visualized
•A significant stenosis proximal to the stenotic anastomosis
•The concomitant use of other oral drugs containing budesonide within 4 weeks of screening
•Pregnancy, lactation, or intended pregnancy within 9 months
•Serious secondary illnesses of an acute or chronic nature (e.g., acute cardiovascular disease, active infection)
•Known intolerance/hypersensitivity to the study drug
•Well-founded doubt about the patient’s cooperation and/or compliance

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