Endoscopic stricturotomy vs balloon dilation for small bowel Crohn’s stricture

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this multicenter, open-label study, adults with Crohn’s disease and a small bowel fibrotic stricture will be randomized to receive either endoscopic stricturotomy or endoscopic balloon dilation. The primary focus is safety, specifically procedure-related bleeding or perforation. A secondary aim is to assess immediate technical success, defined as the ability of the enteroscope to pass through the treated stricture after the procedure. The trial seeks to determine if endoscopic stricturotomy is a feasible endoscopic option for these strictly fibrotic lesions. Results will inform whether the new approach can be considered a viable alternative to balloon dilation in clinical practice.

Why it matters

Who can join: the full rules

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.

Where it's running

• The Sixth Affiliated Hospital, Sun Yat-sen University
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Qin Guo, MD
• Email: guoq83@mail.sysu.edu.cn
• Phone: +86-13507406889

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.