Comparing Endoscopic Strictureplasty vs. Balloon Dilation in Crohn's Disease Strictures
Recruiting · NCT06203782 · Interventional (participants receive a specific treatment) · Lead sponsor: Second Affiliated Hospital, Zhejiang University, School of Medicine
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
Inclusion criteria
- 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 criteria
- 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.
Where it is running
1 location listed.
- 浙江大学医学院第二附属医院 - Hangzhou, Hangzhou, China