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

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
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.
Trial Details
NCT Number NCT07833332
Lead Sponsor Sixth Affiliated Hospital, Sun Yat-sen University
Collaborators: First Affiliated Hospital, Sun Yat-Sen University, Sir Run Run Shaw Hospital, Air Force Military Medical University, China, Second Xiangya Hospital of Central South University, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Conditions
(from sponsor)		 Crohn Disease (CD), Intestinal Stricture, Intestinal Fibrosis
Related terms Crohn Disease
Enrollment 244 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov