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

NCT07833332 | Recruiting

• 2 other identifiers: 1010CG(2023)-022024ZSLYEC-054
• Study Type: interventional
• Target: 244
• Locations: 1 country
• Sites: 1

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.

Conditions

Crohn Disease (CD); Intestinal Stricture; Intestinal Fibrosis

Keywords

Endoscopic Stricturotomy; Endoscopic Balloon Dilation; Small Bowel Stricture; Fibrotic Stricture; Balloon-Assisted Enteroscopy

Outcome Measures

Primary Outcomes (1)

• 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.

  During and immediately after the endoscopic procedure

Secondary Outcomes (1)

• Percentage of Treated Small Bowel Strictures With Technical Success

  Immediately after the endoscopic procedure

Other Outcomes (3)

• Crohn's Disease Obstructive Score (CDOS)

  1 year

• Crohn's Disease Activity Index (CDAI)

  1 year

• Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score

  1 year

Study Arms (2)

Endoscopic Stricturotomy

EXPERIMENTAL

Participants assigned to this arm will undergo endoscopic stricturotomy for Crohn's disease-related small bowel fibrotic strictures. The stricture will be incised endoscopically until adequate luminal enlargement is achieved, followed by endoscopic reassessment of the treated stricture.

Procedure: Endoscopic Stricturotomy

Endoscopic Balloon Dilation

ACTIVE COMPARATOR

Participants assigned to this arm will undergo endoscopic balloon dilation for Crohn's disease-related small bowel fibrotic strictures. The stricture will be dilated endoscopically using a dilation balloon, followed by endoscopic reassessment of the treated stricture.

Procedure: Endoscopic Balloon Dilation

Interventions

Endoscopic Stricturotomy PROCEDURE

Endoscopic 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.

Also known as: ES

Endoscopic Stricturotomy

Endoscopic Balloon Dilation PROCEDURE

Endoscopic 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.

Endoscopic Balloon Dilation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• Hemoglobin \<5 g/dL;
• White blood cell count \<3 × 10\^9/L;
• Platelet count \<100 × 10\^9/L or \>1200 × 10\^9/L;

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead
• 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

Study Sites (1)

The Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510655, China

RECRUITING

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Central Study Contacts

Qin Guo, MD

CONTACT

+86-13507406889; guoq83@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomly assigned in a 1:1 ratio to endoscopic stricturotomy or endoscopic balloon dilation in a multicenter, open-label, parallel-group trial.

Study Record Dates

• First Submitted: September 15, 2026
• First Posted: September 22, 2026
• Study Start: February 18, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 22, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)