Comparison of the Therapeutic Effects of Balloon Assisted Enteroscopy Assisted Narrow Incision an… (NCT07409376) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Comparison of the Therapeutic Effects of Balloon Assisted Enteroscopy Assisted Narrow Incision and Balloon Dilation in the Treatment of Crohn's Disease Small Intestinal Stenosis
100 participantsStarted 2026-03-01
Plain-language summary
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.
Who can participate
Age range16 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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.
✓. Signed informed consent form.
Exclusion criteria
✕. 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.
What they're measuring
1
Proportion of patients not requiring additional therapeutic interventions at 1-year follow-up
Timeframe: 1 year
Trial details
NCT IDNCT07409376
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University