RecruitingNCT07833332Updated Sep 22, 2026

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

An interventional study of Endoscopic Stricturotomy and Endoscopic Balloon Dilation in Crohn Disease (CD), Intestinal Stricture and Intestinal Fibrosis, sponsored by Sixth Affiliated Hospital, Sun Yat-sen University. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-22.

Sponsored by Sixth Affiliated Hospital, Sun Yat-sen University · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 244
Allocation: Randomized
Ages: 18 Years to 70 Years
Sex: All

Study 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.

Read the detailed description

Fibrotic intestinal strictures are an important complication of Crohn's disease. Medical therapy can effectively control intestinal inflammation, but established fibrotic strictures may respond poorly to medical treatment and may require endoscopic or surgical intervention. Endoscopic balloon dilation is commonly used for selected Crohn's disease-related strictures, but limitations include recurrence and the potential need for repeated procedures or surgery. Endoscopic stricturotomy is an alternative endoscopic approach that directly incises the fibrotic stricture and may provide another treatment option for patients with Crohn's disease-related small bowel strictures.

This study is a multicenter, open-label, randomized, parallel-group controlled trial comparing endoscopic stricturotomy with endoscopic balloon dilation in patients with Crohn's disease and small bowel fibrotic strictures. Participants who meet the eligibility criteria will be randomly allocated to one of the two endoscopic treatment groups.

In the endoscopic stricturotomy group, the fibrotic stricture will be incised endoscopically until adequate luminal enlargement is achieved. In the endoscopic balloon dilation group, the stricture will be dilated endoscopically using a dilation balloon. After treatment, the treated stricture will be reassessed endoscopically.

The study primarily aims to compare the safety of the two endoscopic approaches and secondarily to compare their immediate technical effectiveness.

Conditions studied

Crohn Disease (CD)
Intestinal Stricture
Intestinal Fibrosis

Browse trials for

Crohn Disease 1,875

Keywords

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

Who can participate

Ages eligible: 18 Years to 70 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 244 participants (estimated)

Study arms

Experimental
Endoscopic Stricturotomy
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
Active comparator
Endoscopic Balloon Dilation
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

ProcedureEndoscopic Stricturotomy
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
ProcedureEndoscopic Balloon Dilation
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.

What researchers measure

Primary outcomes

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.
Time frame: During and immediately after the endoscopic procedure

Secondary outcomes

Percentage of Treated Small Bowel Strictures With Technical Success
Technical success is defined as successful passage of the enteroscope through the treated small bowel stricture after endoscopic stricturotomy or endoscopic balloon dilation. The percentage will be calculated as the number of treated strictures through which the enteroscope can successfully pass divided by the total number of treated strictures, multiplied by 100.
Time frame: Immediately after the endoscopic procedure

Other outcomes

Crohn's Disease Obstructive Score (CDOS)
The Crohn's Disease Obstructive Score (CDOS) is used to assess the severity of obstructive symptoms in patients with Crohn's disease. The score includes six components related to obstructive abdominal pain, nausea or vomiting, dietary restriction, and hospitalization. The total score ranges from 0 to 6, with higher scores indicating more severe obstructive symptoms.
Time frame: 1 year
Crohn's Disease Activity Index (CDAI)
The Crohn's Disease Activity Index (CDAI) is used to assess Crohn's disease activity based on eight clinical variables. A CDAI score below 150 indicates clinical remission; scores of 150-220, 221-450, and above 450 indicate mild, moderate, and severe disease activity, respectively.
Time frame: 1 year
Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score
The Inflammatory Bowel Disease Questionnaire (IBDQ) is a 32-item disease-specific questionnaire used to assess health-related quality of life. The total score ranges from 32 to 224, with higher scores indicating better health-related quality of life.
Time frame: 1 year

Study locations

1 of 1 sites recruiting

The Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong 510655, China
- Qin Guo, MD · Contact · guoq83@mail.sysu.edu.cn · +86-13507406889
Recruiting

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Registry details

Key details

Study ID: NCT07833332
Lead sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Collaborators: First Affiliated Hospital, Sun Yat-Sen University, Sir Run Run Shaw Hospital, Air Force Military Medical University, China, Second Xiangya Hospital of Central South University, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Responsible party: Sponsor
First posted: Sep 22, 2026
Start date: Feb 18, 2024
Primary completion: Dec 2027 (estimated)
Completion: Dec 2027 (estimated)
Last update: Sep 22, 2026

Study contacts

Qin Guo, MD

Contact

guoq83@mail.sysu.edu.cn

+86-13507406889

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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