Actively Recruiting
Comparing Endoscopic Strictureplasty vs. Balloon Dilation in Crohn's Disease Strictures
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2025-06-15
102
Participants Needed
1
Research Sites
54 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 ulcers are the primary manifestations. However, as the disease progresses and recurs over the years, even with medication treatment, 30%-50% of patients continue to experience varying degrees of intestinal narrowing, with a percentage of it being irreversible fibrotic strictures. For CD-associated intestinal fibrotic strictures, drug therapy often yields limited results, and long-term use of biologics may potentially induce or worsen intestinal narrowing. In comparison to medical treatment, surgical intervention offers a more definitive solution for intestinal strictures. However, surgical treatment is invasive and comes with risks of postoperative complications and disease recurrence. Endoscopic therapy serves as a bridge between medical and surgical treatment options. Key techniques of endoscopic therapy include endoscopic balloon dilation (EBD), endoscopic stricturoplasty (EST), and endoscopic stent placement.
CONDITIONS
Official Title
Comparing Endoscopic Strictureplasty vs. Balloon Dilation in Crohn's Disease Strictures
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years old
- Clear evidence of primary or secondary strictures in Crohn's disease confirmed by imaging and endoscopy
- Colonoscopy can reach the stricture site
- If previously treated endoscopically, asymptomatic for at least one year
- Complete or partial intestinal obstruction
- Traditional and step-up treatments have been ineffective
- Stricture length less than 5 cm
- Maximum of two strictures
- Signed informed consent
You will not qualify if you...
- Strictures with abscesses, fistulas, or active lesions beyond the stricture site
- Strictures previously treated with stents or dilation without symptom relief for over one year
- Pregnancy or breastfeeding
- Unable to undergo endoscopic treatment
- Severe blood clotting disorders (platelet count below 70,000 or INR above 1.5)
- Advanced tumors or severe systemic diseases
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
浙江大学医学院第二附属医院
Hangzhou, Hangzhou, China, 310000
Actively Recruiting
Research Team
Y
Yan Chen, phd
CONTACT
Q
Qiao Yu, phd
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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