Endoscopic strictureplasty versus balloon dilation for Crohn's intestinal strictures

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.