This multicenter, open-label, randomized controlled trial aims to compare the safety and immediate effectiveness of endoscopic stricturotomy (ES) and endoscopic balloon dilation (EBD) for the treatment of small bowel fibrotic strictures in patients with Crohn's disease. Eligible participants with Crohn's disease and small bowel fibrotic strictures will be randomly assigned to receive either endoscopic stricturotomy or endoscopic balloon dilation. The study will compare procedure-related bleeding or perforation between the two treatment groups and will also evaluate immediate technical success, defined by whether the enteroscope can pass through the treated stricture after the procedure. The study is intended to provide clinical evidence on the safety and feasibility of endoscopic stricturotomy as an endoscopic treatment option for small bowel fibrotic strictures in Crohn's disease.
Fibrotic intestinal strictures are an important complication of Crohn's disease. Medical therapy can effectively control intestinal inflammation, but established fibrotic strictures may respond poorly to medical treatment and may require endoscopic or surgical intervention. Endoscopic balloon dilation is commonly used for selected Crohn's disease-related strictures, but limitations include recurrence and the potential need for repeated procedures or surgery. Endoscopic stricturotomy is an alternative endoscopic approach that directly incises the fibrotic stricture and may provide another treatment option for patients with Crohn's disease-related small bowel strictures. This study is a multicenter, open-label, randomized, parallel-group controlled trial comparing endoscopic stricturotomy with endoscopic balloon dilation in patients with Crohn's disease and small bowel fibrotic strictures. Participants who meet the eligibility criteria will be randomly allocated to one of the two endoscopic treatment groups. In the endoscopic stricturotomy group, the fibrotic stricture will be incised endoscopically until adequate luminal enlargement is achieved. In the endoscopic balloon dilation group, the stricture will be dilated endoscopically using a dilation balloon. After treatment, the treated stricture will be reassessed endoscopically. The study primarily aims to compare the safety of the two endoscopic approaches and secondarily to compare their immediate technical effectiveness.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
244
Endoscopic stricturotomy is performed for the small bowel fibrotic stricture using an endoscopic incision knife. The stricture is incised in a partial or circumferential manner until adequate luminal enlargement is achieved. Hemostasis is performed if necessary, and the treated stricture is reassessed endoscopically after the procedure.
Endoscopic balloon dilation is performed for the small bowel fibrotic stricture using a dilation balloon introduced over a guidewire. The stricture is dilated endoscopically and reassessed after the procedure to determine whether the enteroscope can pass through the treated stricture.
The Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGPercentage of Treated Small Bowel Strictures With Procedure-Related Bleeding or Perforation
The primary outcome is the percentage of treated small bowel strictures with procedure-related bleeding or perforation after endoscopic stricturotomy or endoscopic balloon dilation. The percentage will be calculated as the number of treated strictures with bleeding or perforation divided by the total number of treated strictures, multiplied by 100.
Time frame: During and immediately after the endoscopic procedure
Percentage of Treated Small Bowel Strictures With Technical Success
Technical success is defined as successful passage of the enteroscope through the treated small bowel stricture after endoscopic stricturotomy or endoscopic balloon dilation. The percentage will be calculated as the number of treated strictures through which the enteroscope can successfully pass divided by the total number of treated strictures, multiplied by 100.
Time frame: Immediately after the endoscopic procedure
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