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.
Age 18 to 70 years.
Diagnosis of Crohn's disease for at least 3 months before screening, based on clinical manifestations and endoscopic and/or imaging findings, with histopathological support.
Presence of a small bowel stricture that prevents passage of the enteroscope.
Clinical manifestations of partial intestinal obstruction;
Anastomotic stricture.
Deep or large ulceration at the stricture site.
Marked angulation or sharp bending at the stricture site.
An absolute indication for surgical treatment, including acute perforation, major bleeding that cannot be managed medically or endoscopically, intra-abdominal abscess, small bowel fistula, or malignancy.
Parallel
Endoscopic Stricturotomy
Procedure/SurgeryEndoscopic 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.
Endoscopic Balloon Dilation
Procedure/SurgeryEndoscopic 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.
Percentage of Treated Small Bowel Strictures With Procedure-Related Bleeding or Perforation
The primary outcome is the percentage of treated small bowel strictures with procedure-related bleeding or perforation after endoscopic stricturotomy or endoscopic balloon dilation. The percentage will be calculated as the number of treated strictures with bleeding or perforation divided by the total number of treated strictures, multiplied by 100.
Percentage of Treated Small Bowel Strictures With Technical Success
Technical success is defined as successful passage of the enteroscope through the treated small bowel stricture after endoscopic stricturotomy or endoscopic balloon dilation. The percentage will be calculated as the number of treated strictures through which the enteroscope can successfully pass divided by the total number of treated strictures, multiplied by 100.
Crohn's Disease Obstructive Score (CDOS)
The Crohn's Disease Obstructive Score (CDOS) is used to assess the severity of obstructive symptoms in patients with Crohn's disease. The score includes six components related to obstructive abdominal pain, nausea or vomiting, dietary restriction, and hospitalization. The total score ranges from 0 to 6, with higher scores indicating more severe obstructive symptoms.
Crohn's Disease Activity Index (CDAI)
The Crohn's Disease Activity Index (CDAI) is used to assess Crohn's disease activity based on eight clinical variables. A CDAI score below 150 indicates clinical remission; scores of 150-220, 221-450, and above 450 indicate mild, moderate, and severe disease activity, respectively.
Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score
The Inflammatory Bowel Disease Questionnaire (IBDQ) is a 32-item disease-specific questionnaire used to assess health-related quality of life. The total score ranges from 32 to 224, with higher scores indicating better health-related quality of life.
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Sixth Affiliated Hospital, Sun Yat-sen University
Lead sponsor
First Affiliated Hospital, Sun Yat-Sen University
Collaborator
Sir Run Run Shaw Hospital
Collaborator
Air Force Military Medical University, China
Collaborator
Second Xiangya Hospital of Central South University
Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Collaborator
