🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT06203782
Recruiting Not applicable

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

NCT06203782 · tracked via the Priya Life Science China tracker
Sponsor
Second Affiliated Hospital, Zhejiang University, School of Medicine
Phase
Not applicable
Started
2024-12-16
Last updated
2025-06-15

Condition(s) studied

Crohn Disease

Investigational drug(s) / intervention(s)

endoscopic stricturoplastyendoscopic balloon dilation

endoscopic 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.

endoscopic 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.

Study 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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
浙江大学医学院第二附属医院 Hangzhou Hangzhou Recruiting

More Second Affiliated Hospital, Zhejiang University, School of Medicine trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06203782 on ClinicalTrials.gov ↗ ← All trials in China