Endoscopic strictureplasty versus balloon dilation for Crohn's intestinal 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
This will test whether endoscopic strictureplasty or balloon dilation works better to open intestinal narrowings caused by Crohn's disease in adults 18 to 75.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 102 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University Academic / other |
| Locations | 1 site (Hangzhou, Hangzhou) |
| Trial ID | NCT06203782 on ClinicalTrials.gov |
What this trial studies
This interventional trial directly compares two endoscopic techniques—strictureplasty and balloon dilation—to treat fibrotic intestinal strictures from Crohn's disease. Eligible adults with up to two strictures under 5 cm that can be reached by colonoscopy will receive one of the procedures, with prior endoscopic treatment allowed if the patient has been asymptomatic for at least one year. Key exclusions include active abscesses, fistulas or lesions beyond the stricture, pregnancy, severe coagulopathy, and advanced malignancy. Procedures and follow-up are conducted at Zhejiang University's Second Affiliated Hospital with outcomes focused on symptom relief, need for repeat procedures or surgery, and safety.
Who should consider this trial
Good fit: Adults 18–75 with one or two Crohn's-related strictures under 5 cm in length that are reachable by colonoscopy and who meet the other inclusion and exclusion criteria.
Not a fit: Patients with active abscesses, fistulas, widespread inflammatory lesions, inability to undergo endoscopy, pregnancy, severe clotting problems, or advanced cancers are unlikely to benefit from the interventions tested here.
Why it matters
Potential benefit: If successful, a less invasive endoscopic approach could relieve obstruction and reduce the need for surgery for some patients.
How similar studies have performed: Balloon dilation is an established endoscopic option for Crohn's strictures, while endoscopic stricturoplasty is a newer technique with limited but growing positive reports.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Hangzhou, Hangzhou
- 浙江大学医学院第二附属医院 — Hangzhou, Hangzhou, China (Recruiting)
Study contacts
- Study coordinator: Yan Chen, phd
- Email: chenyan72_72@zju.edu.cn
- Phone: 13757118653
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.