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

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.