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

Starting soon · Not applicable

Conditions studied: CD - Crohn's Disease

In brief

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.

Key facts

Study ID

NCT07409376

Run by

Second Affiliated Hospital, Zhejiang University, School of Medicine

People needed

100

Starts

2026-03-01

Expected to finish

2028-12-31

Last updated by the study team

2026-02-13

Who can join

Age: 16 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• Small bowel stricture complicated by abscess, fistula, or severe angulation.
• Patients with ≥3 small bowel strictures or stricture length ≥5 cm.
• Strictures previously treated with stent placement, dilation, or incision but without sustained symptom-free remission for at least 1 year.
• Pregnancy or breastfeeding.
• Inability to undergo endoscopic treatment.
• Severe coagulation disorders (platelet count <70,000/μL, INR >1.5).
• Concomitant advanced tumors or other severe organ diseases.
• Suspected localized intestinal malignancy.

Full record on ClinicalTrials.gov

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