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)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: CD - Crohn's Disease
• Intervention / Treatment: Procedure: No Interventions; Procedure: balloon dilation; Procedure: stricture incision

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shenglong Xia, Phd; Phone Number: +86-19857128950; Email: xsl89@zju.edu.cn
• Study Contact Backup: Name: Surong Hu, PhD; Phone Number: +86-15868532956; Email: 526315332@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: No Intervention; 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.	Procedure: No Interventions; No Intervention
Experimental: Balloon-assisted enteroscopy-guided balloon dilation; Patients in this arm will undergo balloon dilation of small bowel strictures under balloon-assisted enteroscopy to relieve luminal narrowing.	Procedure: balloon dilation; Balloon-assisted enteroscopy-guided balloon dilation
Experimental: Balloon-assisted enteroscopy-guided stricture incision; Patients in this arm will receive balloon-assisted enteroscopy-guided radial incision of small bowel strictures under direct endoscopic visualization.	Procedure: stricture incision; Balloon-assisted enteroscopy-guided stricture incision versus balloon dilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 years
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.	5 years
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.	Within 2 months post-procedure
Immediate technical success of the procedure	Assessment of successful passage of the endoscope through the stricture immediately after balloon dilation or stricture incision.	At the time of procedure
Symptom-free duration within 1 year post-procedure	Duration of symptom-free period within 1 year after the procedure, defined as a score ≤1 on the obstruction symptom assessment scale.	1 year
Cost analysis of the two treatment methods	Comparative analysis of medical costs associated with balloon dilation versus stricture incision, including procedure, hospitalization, and follow-up expenses.	Up to 1 year post-procedure

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Principal Investigator: Yan Chen, PhD, Second Affiliated Hospital of Zhejiang University School of Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: February 9, 2026
• First Submitted That Met QC Criteria: February 12, 2026
• First Posted (Actual): February 13, 2026

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 12, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Crohn's Disease; balloon-assisted enteroscopy; stricture
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Pathological Conditions, Signs and Symptoms; Constriction, Pathologic; Crohn Disease
• Other Study ID Numbers: 2025-1188

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No