This study is designed as a controlled trial to evaluate the efficacy of balloon-assisted enteroscopy-guided radial incision therapy for the treatment of stricturing small bowel Crohn's disease. The study aims to compare therapeutic outcomes, procedure-related complications, and recurrence rates in patients with stricturing small bowel Crohn's disease undergoing balloon-assisted enteroscopy-guided radial incision therapy. The results are expected to provide a novel and reliable treatment option for patients with stricturing Crohn's disease and to lay a foundation for improving disease-related symptoms and quality of life.
Age between 16 and 75 years.
Diagnosis of Crohn's disease with primary or secondary small bowel stricture confirmed by imaging studies, or small bowel stricture identified by enteroscopy.
Inadequate response to conventional medical therapy and step-up treatment strategies.
Stricture length less than 5 cm.
Bowel wall thickening with Limberg grade IV blood flow on intestinal ultrasound, or presence of complications such as perforation, fistula, deep ulcer, inflammatory mass, or abscess.
Deep ulcer in the stricture segment observed by enteroscopy, potentially involving the muscular layer.
Presence of strictures in the esophagus, stomach, or duodenum.
Presence of colorectal stricture or ileocecal valve stricture.
Parallel
stricture incision
Procedure/SurgeryBalloon-assisted enteroscopy-guided stricture incision versus balloon dilation
balloon dilation
Procedure/SurgeryBalloon-assisted enteroscopy-guided balloon dilation
No Interventions
Procedure/SurgeryNo Intervention
Proportion of patients not requiring additional therapeutic interventions at 1-year follow-up
Percentage of patients who do not require any new therapeutic intervention, including endoscopic balloon dilation (EBD), endoscopic stricture incision (EST), or surgery, within 1 year after the initial procedure.
Proportion of patients not requiring additional therapeutic interventions at 3-year follow-up
Percentage of patients who do not require any new therapeutic intervention (EBD, EST, or surgery) within 3 years after the initial procedure.
Proportion of patients not requiring additional therapeutic interventions at 5-year follow-up
Percentage of patients who do not require any new therapeutic intervention (EBD, EST, or surgery) within 5 years after the initial procedure.
Safety assessment of the two treatment methods
Evaluation of procedure-related complications, including postoperative bleeding, perforation, and any adverse events (AEs) or serious adverse events (SAEs) occurring within 2 months after the procedure.
Immediate technical success of the procedure
Assessment of successful passage of the endoscope through the stricture immediately after balloon dilation or stricture incision.
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