NCT06203782Recruiting
Comparing Endoscopic Strictureplasty vs. Balloon Dilation in Crohn's Disease Strictures
Comparison of Endoscopic Strictureplasty and Endoscopic Balloon Dilation for the Treatment of Crohn's Disease Intestinal Strictures: An Open-Label, Multicenter, Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 15 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 102 (estimated)
- First submitted
- 28 Sept 2023
- Start date
- 16 Dec 2024
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Diseases
- Crohn's disease
- NCT number
- NCT06203782
What you commit to
- Study type: Interventional
- Planned participants: 102
- From 16 Dec 2024 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Strictures that have previously been treated with stents or dilation, but without symptomatic relief maintained for more than one year.
- Concurrent advanced-stage tumors or other severe systemic comorbidities.
Lab values
- Pregnancy or lactation. Inability to undergo endoscopic treatment. Severe coagulation disorders (platelet count less than 70,000, INR greater than 1.5).
Other
- Strictures complicated by abscesses, fistulas, or other active lesions that are not confined to the stricture site.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.