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 (CD stenosis)

Zhejiang University

Status: Not yet enrolling

Conditions: CD - Crohn's Disease

Treatments: Procedure: balloon dilation; Procedure: stricture incision; Procedure: No Interventions

Study type: Interventional

Funder types: Other

Identifiers

NCT07409376

2025-1188

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 16 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age between 16 and 75 years.
2. Diagnosis of Crohn's disease with primary or secondary small bowel stricture confirmed by imaging studies, or small bowel stricture identified by enteroscopy.
3. Inadequate response to conventional medical therapy and step-up treatment strategies.
4. Stricture length less than 5 cm.
5. Signed informed consent form.

Exclusion criteria

1. 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.
2. Deep ulcer in the stricture segment observed by enteroscopy, potentially involving the muscular layer.
3. Presence of strictures in the esophagus, stomach, or duodenum.
4. Presence of colorectal stricture or ileocecal valve stricture.
5. Small bowel stricture complicated by abscess, fistula, or severe angulation.
6. Patients with ≥3 small bowel strictures or stricture length ≥5 cm.
7. Strictures previously treated with stent placement, dilation, or incision but without sustained symptom-free remission for at least 1 year.
8. Pregnancy or breastfeeding.
9. Inability to undergo endoscopic treatment.
10. Severe coagulation disorders (platelet count <70,000/μL, INR >1.5).
11. Concomitant advanced tumors or other severe organ diseases.
12. Suspected localized intestinal malignancy.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 3 patient groups

No Intervention

Sham Comparator group

Description:

Patients in this arm will not receive endoscopic interventional treatment for small bowel strictures and will be managed with standard medical therapy and clinical observation.

Treatment:

Procedure: No Interventions

Balloon-assisted enteroscopy-guided balloon dilation

Experimental group

Description:

Patients in this arm will undergo balloon dilation of small bowel strictures under balloon-assisted enteroscopy to relieve luminal narrowing.

Treatment:

Procedure: balloon dilation

Balloon-assisted enteroscopy-guided stricture incision

Experimental group

Description:

Patients in this arm will receive balloon-assisted enteroscopy-guided radial incision of small bowel strictures under direct endoscopic visualization.

Treatment:

Procedure: stricture incision