CD - Crohn's Disease
Conditions
Keywords
Crohn's Disease; balloon-assisted enteroscopy; stricture
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.
Interventions
PROCEDUREstricture incision
Balloon-assisted enteroscopy-guided stricture incision versus balloon dilation
PROCEDUREballoon dilation
Balloon-assisted enteroscopy-guided balloon dilation
PROCEDURENo Interventions
No Intervention
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients not requiring additional therapeutic interventions at 1-year follow-up | 1 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients not requiring additional therapeutic interventions at 3-year follow-up | 3 years | Percentage of patients who do not require any new therapeutic intervention (EBD, EST, or surgery) within 3 years after the initial procedure. |
| Proportion of patients not requiring additional therapeutic interventions at 5-year follow-up | 5 years | Percentage of patients who do not require any new therapeutic intervention (EBD, EST, or surgery) within 5 years after the initial procedure. |
| Safety assessment of the two treatment methods | Within 2 months post-procedure | 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. |
| Immediate technical success of the procedure | At the time of procedure | Assessment of successful passage of the endoscope through the stricture immediately after balloon dilation or stricture incision. |
| Symptom-free duration within 1 year post-procedure | 1 year | Duration of symptom-free period within 1 year after the procedure, defined as a score ≤1 on the obstruction symptom assessment scale. |
| Cost analysis of the two treatment methods | Up to 1 year post-procedure | Comparative analysis of medical costs associated with balloon dilation versus stricture incision, including procedure, hospitalization, and follow-up expenses. |
Contacts
CONTACTShenglong Xia, Phd
CONTACTSurong Hu, PhD
PRINCIPAL_INVESTIGATORYan Chen, PhD
Second Affiliated Hospital of Zhejiang University School of Medicine
Outcome results
None listed