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

NCT06203782 | Recruiting DMC

• 1 other identifier: 2023-0877
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Crohn Disease

Outcome Measures

Primary Outcomes (1)

• Remission rate of patients

  Number of patients who did not require new endoscopic or surgical treatment due to symptom recurrence within one year of follow-up, quantified and reported.

  1 year

Secondary Outcomes (1)

• Safety of both treatment modalities

  1 year

Study Arms (2)

Experimental Group

EXPERIMENTAL

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.

Procedure: endoscopic stricturoplasty

Control Group

EXPERIMENTAL

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.

Procedure: endoscopic balloon dilation

Interventions

endoscopic stricturoplasty PROCEDURE

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.

Experimental Group

endoscopic balloon dilation PROCEDURE

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.

Control Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

浙江大学医学院第二附属医院

Hangzhou, Hangzhou, 310000, China

RECRUITING

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Yan Chen, phd

  Department of Gastroenterology, Second Affiliated Hospital, School of Medicine, Zhejiang University

  STUDY CHAIR

Central Study Contacts

Yan Chen, phd

CONTACT

13757118653; chenyan72_72@zju.edu.cn

Qiao Yu, phd

CONTACT

13456820567; yuqiao@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2023
• First Posted: January 12, 2024
• Study Start: December 16, 2024
• Primary Completion: December 31, 2025
• Study Completion: January 1, 2026
• Last Updated: June 15, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: now is available
• Access Criteria: All the doctors

Locations

CN (1)