Status:
RECRUITING
Comparing Endoscopic Strictureplasty vs. Balloon Dilation in Crohn's Disease Strictures
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Conditions:
Crohn Disease
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Crohn's disease (CD) is an inflammatory bowel disease characterized by chronic ulcers, strictures, and penetrating lesions in the intestinal tract. In the early stages of the disease, inflammation and...
Detailed Description
Inflammatory Bowel Disease (IBD) is a group of chronic, recurrent, nonspecific inflammatory disorders of the gastrointestinal tract, the etiology of which remains unclear. It primarily encompasses Ulc...
Eligibility Criteria
Inclusion
- Age between 18 and 75 years old. Clear evidence of primary or secondary strictures in Crohn's disease that can be identified through imaging and endoscopy (colonoscopy can reach the site).
- If the patient has previously undergone endoscopic treatment, they must have remained asymptomatic for at least one year.
- Complete or partial intestinal obstruction. Ineffectiveness of traditional and step-up treatment approaches. Stricture length less than 5 cm. A maximum of two strictures. Signed informed consent.
Exclusion
- Strictures complicated by abscesses, fistulas, or other active lesions that are not confined to the stricture site.
- Strictures that have previously been treated with stents or dilation, but without symptomatic relief maintained for more than one year.
- Pregnancy or lactation. Inability to undergo endoscopic treatment. Severe coagulation disorders (platelet count less than 70,000, INR greater than 1.5).
- Concurrent advanced-stage tumors or other severe systemic comorbidities.
Key Trial Info
Start Date :
December 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT06203782
Start Date
December 16 2024
End Date
January 1 2026
Last Update
June 15 2025
Active Locations (1)
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1
浙江大学医学院第二附属医院
Hangzhou, Hangzhou, China, 310000