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

Korábbi kezelés

• Active tuberculosis, including findings suspicious for pulmonary tuberculosis on chest radiography performed within 3 months before Week 0.
• A clinically significant infection, such as pneumonia or pyelonephritis, within 30 days before screening, or an ongoing chronic infection.

Más betegség

• 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.
• Any confirmed congenital or acquired immunodeficiency, including human immunodeficiency virus (HIV) infection or organ transplantation.
• 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 other condition that, in the investigator's opinion, makes the participant unsuitable for endoscopic or surgical treatment.

Laborértékek

• Any of the following laboratory abnormalities during screening:
  • Hemoglobin \<5 g/dL;
  • White blood cell count \<3 × 10\^9/L;
  • Platelet count \<100 × 10\^9/L or \>1200 × 10\^9/L;
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>3 times the upper limit of normal (ULN); or
  • Serum creatinine \>2 times the ULN.

Egyéb

• Anastomotic stricture.
• Deep or large ulceration at the stricture site.
• Marked angulation or sharp bending at the stricture site.
• 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.

• 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:
  • Clinical manifestations of partial intestinal obstruction;
  • Small bowel stricture identified by endoscopy (with a lumen narrower than the distal end of the enteroscope) or computed tomography enterography (CTE); and
  • 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.