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

N/ANot Yet RecruitingNCT07409376

Second Affiliated Hospital, School of Medicine, Zhejiang University100 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

CD - Crohn's Disease

Interventions

Eligibility

Sex: ALLMin age: 16 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 1 year

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Up to 1 year post-procedure

Central Contacts

Shenglong Xia, Phd

CONTACT

+86-19857128950 xsl89@zju.edu.cn

Surong Hu, PhD

CONTACT

+86-15868532956 526315332@qq.com