Stenosis is one of the most frequent complications in patients with Crohn's disease (CD). In particular, CD patients with intestinal strictures are often faced with short bowel syndrome after repeated or extensive surgical resection. Endoscopic management shows good efficacy and safety in the treatment of strictures in CD patients. The European Crohn's and Colitis Organisation (ECCO) guideline recommended that endoscopic balloon dilatation is suitable to treat short \[\<5 cm\] strictures of the terminal ileum in CD. Recently, Lan et al. reported that endoscopic stricturotomy appeared to be more effective in treating CD patients with anastomotic stricture than endoscopic balloon dilatation. However, there is no prospective clinical studies evaluating the efficacy and safety of endoscopic stricturotomy in the treatment of fibrostenotic Crohn's disease. The trial aims to compare the efficacy and safety of endoscopic stricturotomy with endoscopic balloon dilation in the treatment of small bowel stricture in patients with Crohn's Disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
96
Endoscopic stricturotomy for bowel stricture (\<5 cm)
Endoscopic balloon dilatation for bowel stricture (\<5 cm)
The Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGSurgery-free survival
Percentage of patients who do not receive surgical intervention for obstruction recurrence
Time frame: 52 weeks
Endoscopic intervention-free survival
Percentage of patients who do not receive endoscopic intervention for obstruction recurrence
Time frame: 52 weeks
Intervention-free survival
Percentage of patients who do not receive surgical or endoscopic intervention for obstruction recurrence
Time frame: Week 52
Technical success rate
The passage of endoscope without resistance
Time frame: Week 0
Obstructive score change
Obstructive score (scaling from 0 to 6, higher scores mean a worse outcome) change compared to baseline
Time frame: Week 8, 16, 26, 52
Crohn's Disease Activity Index (CDAI) score change
Higher scores mean a worse outcome for CDAI score
Time frame: Week 8, 16, 26, 52
Inflammatory Bowel Disease Questionnaire (IBDQ) score reduction
Higher scores mean a better outcome for IBDQ score
Time frame: Week 8, 16, 26, 52
Adverse event rate
Percentage of adverse events
Time frame: Week 52
Total cost
Total cost for intervention
Time frame: Week 52
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