Comparison of Endoscopic Needle-Knife Stricturotomy Versus Endoscopic Balloon Dilation for Small Bowel Fibrotic Strictures in Crohn's Disease: A Multicenter, Open-Label, Randomized Controlled Trial
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.
• Age 18 to 70 years.
• Diagnosis of Crohn's disease for at least 3 months before screening, based on clinical manifestations and endoscopic and/or imaging findings, with histopathological support.
• Presence of a small bowel stricture that prevents passage of the enteroscope.
• Partial intestinal obstruction, meeting the following criteria:
‣ Clinical manifestations of partial intestinal obstruction;
⁃ Small bowel stricture identified by endoscopy (with a lumen narrower than the distal end of the enteroscope) or computed tomography enterography (CTE); and
⁃ Marked dilation of the bowel lumen proximal to the stricture demonstrated by enteroscopy or CTE.
• Written informed consent and any required privacy authorization signed and dated by the participant or the participant's legally authorized representative, as applicable, before initiation of study procedures.
• Female participants of childbearing potential who are sexually active with a non-sterilized male partner must agree to use adequate conventional contraception throughout the study period, beginning at the time of signing the informed consent form.