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RECRUITING
NCT07833332
NA

Endoscopic Stricturotomy Versus Balloon Dilation for Small Bowel Fibrotic Strictures in Crohn's Disease

Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University

View on ClinicalTrials.gov

Summary

This multicenter, open-label, randomized controlled trial aims to compare the safety and immediate effectiveness of endoscopic stricturotomy (ES) and endoscopic balloon dilation (EBD) for the treatment of small bowel fibrotic strictures in patients with Crohn's disease. Eligible participants with Crohn's disease and small bowel fibrotic strictures will be randomly assigned to receive either endoscopic stricturotomy or endoscopic balloon dilation. The study will compare procedure-related bleeding or perforation between the two treatment groups and will also evaluate immediate technical success, defined by whether the enteroscope can pass through the treated stricture after the procedure. The study is intended to provide clinical evidence on the safety and feasibility of endoscopic stricturotomy as an endoscopic treatment option for small bowel fibrotic strictures in Crohn's disease.

Official title: Comparison of Endoscopic Needle-Knife Stricturotomy Versus Endoscopic Balloon Dilation for Small Bowel Fibrotic Strictures in Crohn's Disease: A Multicenter, Open-Label, Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

244

Start Date

2024-02-18

Completion Date

2027-12

Last Updated

2026-09-22

Healthy Volunteers

No

Interventions

PROCEDURE

Endoscopic Stricturotomy

Endoscopic stricturotomy is performed for the small bowel fibrotic stricture using an endoscopic incision knife. The stricture is incised in a partial or circumferential manner until adequate luminal enlargement is achieved. Hemostasis is performed if necessary, and the treated stricture is reassessed endoscopically after the procedure.

PROCEDURE

Endoscopic Balloon Dilation

Endoscopic balloon dilation is performed for the small bowel fibrotic stricture using a dilation balloon introduced over a guidewire. The stricture is dilated endoscopically and reassessed after the procedure to determine whether the enteroscope can pass through the treated stricture.

Locations (1)

The Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China