RecruitingNot ApplicableNCT06203782

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


Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

102 participants

Start Date

Dec 16, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial compares two procedures for treating narrowings (strictures) in the bowel caused by Crohn's disease: balloon dilation (stretching the narrowing with a balloon) versus endoscopic strictureplasty (surgically widening the narrowing using an endoscope, without traditional surgery). **You may be eligible if...** - You are between 18 and 75 years old - You have Crohn's disease with a confirmed bowel stricture (narrowing) that can be reached by colonoscopy - You have partial or complete bowel blockage symptoms - You have not responded adequately to standard medications - The stricture is less than 5 cm long and there are no more than two strictures - If previously treated, you remained symptom-free for at least 1 year afterward **You may NOT be eligible if...** - Your stricture is complicated by abscesses, fistulas, or other active lesions nearby - You have had prior stent placement or dilation without lasting benefit - Your stricture is longer than 5 cm or involves more than two sites Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREendoscopic stricturoplasty

Experimental Group: In the experimental group, 51 patients underwent endoscopic stricturoplasty. A transparent cap was mounted on the front end of the endoscope, and a needle knife was inserted through the working channel of the endoscope. Under direct visualization, a radial incision was made at the site of the stricture, with an effort to preserve normal mucosal tissue as much as possible. The stricture was gradually incised until the endoscope could smoothly pass through.

PROCEDUREendoscopic balloon dilation

Control Group: In the control group, 51 patients underwent endoscopic balloon dilation. The endoscope was advanced to the site of the stricture, and a dilation guidewire was inserted. After placing the balloon, it was progressively inflated with pressure, each inflation lasting 1-2 minutes, and this process was repeated 2-3 times until the endoscope and sheath could pass through the narrowed segment and enter the distal colon.


Locations(1)

浙江大学医学院第二附属医院

Hangzhou, Hangzhou, China

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NCT06203782


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