NCT07833332 Endoscopic Stricturotomy Versus Balloon Dilation for Small Bowel Fibrotic Strictures in Crohn's Disease

Eligibility & Interventions

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This trial targets 244 participants in total. It began in 2024-02-18 with a primary completion date of 2027-12.

Brief 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.

Eligibility Criteria

Inclusion Criteria: * 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. * Partial intestinal obstruction, meeting the following criteria: 1. Clinical manifestations of partial intestinal obstruction; 2. Small bowel stricture identified by endoscopy (with a lumen narrower than the distal end of the enteroscope) or computed tomography enterography (CTE); and 3. Marked dilation of the bowel lumen proximal to the stricture demonstrated by enteroscopy or CTE. * Written informed consent and any required privacy authorization signed and dated by the participant or the participant's legally authorized representative, as applicable, before initiation of study procedures. * Female participants of childbearing potential who are sexually active with a non-sterilized male partner must agree to use adequate conventional contraception throughout the study period, beginning at the time of signing the informed consent form. Exclusion Criteria: * 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. * Inability to tolerate anesthesia, enteroscopy, or surgical treatment because of conditions such as cardiac or pulmonary failure or severe coagulation disorders. * Evidence of active infection during the screening period. * Active tuberculosis, including findings suspicious for pulmonary tuberculosis on chest radiography performed within 3 months before Week 0. * Any confirmed congenital or acquired immunodeficiency, including human immunodeficiency virus (HIV) infection or organ transplantation. * A clinically significant infection, such as pneumonia or pyelonephritis, within 30 days before screening, or an ongoing chronic infection. * Any unstable or uncontrolled cardiovascular, pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematologic, coagulation, immune, endocrine/metabolic, or other medical condition that, in the investigator's opinion, could interfere with study results or compromise participant safety. * History of malignancy. * Any of the following laboratory abnormalities during screening: 1. Hemoglobin \<5 g/dL; 2. White blood cell count \<3 × 10\^9/L; 3. Platelet count \<100 × 10\^9/L or \>1200 × 10\^9/L; 4. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>3 times the upper limit of normal (ULN); or 5. Serum creatinine \>2 times the ULN. * Inability to attend all required study visits or comply with study procedures. * Female participants who are pregnant, plan to become pregnant before or during study participation, or plan to donate ova during this period. * Participants who are coerced into consenting to study participation. * Any other condition that, in the investigator's opinion, makes the participant unsuitable for endoscopic or surgical treatment.

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