NCT07409376Not yet recruiting
Comparison of the Therapeutic Effects of Balloon Assisted Enteroscopy Assisted Narrow Incision and Balloon Dilation in the Treatment of Crohn's Disease Small Intestinal Stenosis
Source: ClinicalTrials.gov · Last updated 13 Feb 2026
Brief summary (registry, in English)
This study is designed as a controlled trial to evaluate the efficacy of balloon-assisted enteroscopy-guided radial incision therapy for the treatment of stricturing small bowel Crohn's disease. The study aims to compare therapeutic outcomes, procedure-related complications, and recurrence rates in patients with stricturing small bowel Crohn's disease undergoing balloon-assisted enteroscopy-guided radial incision therapy. The results are expected to provide a novel and reliable treatment option for patients with stricturing Crohn's disease and to lay a foundation for improving disease-related symptoms and quality of life.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 9 Feb 2026
- Start date
- 1 Mar 2026
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Diseases
- Crohn's disease
- NCT number
- NCT07409376
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 1 Mar 2026 to the primary completion date, 31 Dec 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Strictures previously treated with stent placement, dilation, or incision but without sustained symptom-free remission for at least 1 year.
- Concomitant advanced tumors or other severe organ diseases.
Other illness
- Bowel wall thickening with Limberg grade IV blood flow on intestinal ultrasound, or presence of complications such as perforation, fistula, deep ulcer, inflammatory mass, or abscess.
- Deep ulcer in the stricture segment observed by enteroscopy, potentially involving the muscular layer.
- Small bowel stricture complicated by abscess, fistula, or severe angulation.
- Suspected localized intestinal malignancy.
Lab values
- Severe coagulation disorders (platelet count \<70,000/μL, INR \>1.5).
Other
- Presence of strictures in the esophagus, stomach, or duodenum.
- Presence of colorectal stricture or ileocecal valve stricture.
- Patients with ≥3 small bowel strictures or stricture length ≥5 cm.
- Pregnancy or breastfeeding.
- Inability to undergo endoscopic treatment.
Who the study is looking for
- Age between 16 and 75 years.
- Diagnosis of Crohn's disease with primary or secondary small bowel stricture confirmed by imaging studies, or small bowel stricture identified by enteroscopy.
- Inadequate response to conventional medical therapy and step-up treatment strategies.
- Stricture length less than 5 cm.
- Signed informed consent form.
Age in the registry: 16 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.