Comparing Endoscopic Strictureplasty vs. Balloon Dilation in Crohn's Disease Strictures

Launched by SECOND AFFILIATED HOSPITAL, SCHOOL OF MEDICINE, ZHEJIANG UNIVERSITY · Jan 2, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at two different methods to treat intestinal strictures in people with Crohn's disease. Crohn's disease can cause parts of the intestine to narrow due to inflammation and scarring, making it difficult for food to pass through. The trial will compare endoscopic strictureplasty (a technique that widens the narrowed area by stretching it) and balloon dilation (a method where a balloon is used to open up the stricture) to see which is more effective for patients.

To participate in the trial, you should be between 18 and 75 years old and have a specific type of intestinal narrowing that can be seen during medical imaging or a colonoscopy. You should also have experienced some symptoms from the narrowing and not found relief from standard treatments. However, if you have other complications, such as infections or certain health conditions, you may not be eligible. If you join the trial, you will receive one of the two treatments and be monitored to see how well it works for your condition. This study aims to provide valuable information on less invasive treatment options for Crohn's disease that could improve patients' lives.

Gender

ALL

Eligibility 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.