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

NCT07409376 | Not Yet Recruiting DMC

• 1 other identifier: 2025-1188
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

CD - Crohn's Disease

Keywords

Crohn's Disease; balloon-assisted enteroscopy; stricture

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Proportion of patients not requiring additional therapeutic interventions at 3-year follow-up

  3 years

• Proportion of patients not requiring additional therapeutic interventions at 5-year follow-up

  5 years

• Safety assessment of the two treatment methods

  Within 2 months post-procedure

• Immediate technical success of the procedure

  At the time of procedure

• Symptom-free duration within 1 year post-procedure

  1 year

Study Arms (3)

No Intervention

SHAM COMPARATOR

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

Balloon-assisted enteroscopy-guided balloon dilation

EXPERIMENTAL

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 stricture incision

EXPERIMENTAL

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

Procedure: stricture incision

Interventions

stricture incision PROCEDURE

Balloon-assisted enteroscopy-guided stricture incision versus balloon dilation

Balloon-assisted enteroscopy-guided stricture incision

balloon dilation PROCEDURE

Balloon-assisted enteroscopy-guided balloon dilation

Balloon-assisted enteroscopy-guided balloon dilation

No Interventions PROCEDURE

No Intervention

No Intervention

Eligibility Criteria

• Age: 16 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

MeSH Terms

Conditions

Crohn Disease; Constriction, Pathologic

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Yan Chen, PhD

  Second Affiliated Hospital of Zhejiang University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shenglong Xia, Phd

CONTACT

+86-19857128950; xsl89@zju.edu.cn

Surong Hu, PhD

CONTACT

+86-15868532956; 526315332@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2026
• First Posted: February 13, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: February 13, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share