CD - Crohn's DiseaseCD stenosisNCT07409376
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
A study testing stricture incision and balloon dilation in people with CD - Crohn's Disease, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- CD - Crohn's Disease
- What is being tested?
- stricture incision and balloon dilation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2026to 31 Dec 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- Presence of strictures in the esophagus, stomach, or duodenum.
- Presence of colorectal stricture or ileocecal valve stricture.
- Small bowel stricture complicated by abscess, fistula, or severe angulation.
- Patients with ≥3 small bowel strictures or stricture length ≥5 cm.
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- Strictures previously treated with stent placement, dilation, or incision but without sustained symptom-free remission for at least 1 year.
- Pregnancy or breastfeeding.
- Inability to undergo endoscopic treatment.
- Severe coagulation disorders (platelet count <70,000/μL, INR >1.5).
- Concomitant advanced tumors or other severe organ diseases.
- Suspected localized intestinal malignancy.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Conditions
- CD - Crohn's Disease
- Being tested
- stricture incision, balloon dilation, No Interventions
- Keywords
- Crohn's Disease; balloon-assisted enteroscopy; stricture
- Medical subject headings
- Crohn Disease, Constriction, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stricture incisionProcedure or surgery
Balloon-assisted enteroscopy-guided stricture incision versus balloon dilation
balloon dilationProcedure or surgery
Balloon-assisted enteroscopy-guided balloon dilation
No InterventionsProcedure or surgery
No Intervention
| Study group | Role | What they receive |
|---|---|---|
| No Intervention | Sham comparator | Patients in this arm will not receive endoscopic interventional treatment for small bowel strictures and will be managed with standard medical therapy and clinical observation. Receives: Procedure: No Interventions |
| Balloon-assisted enteroscopy-guided balloon dilation | Experimental | Patients in this arm will undergo balloon dilation of small bowel strictures under balloon-assisted enteroscopy to relieve luminal narrowing. Receives: Procedure: balloon dilation |
| Balloon-assisted enteroscopy-guided stricture incision | Experimental | Patients in this arm will receive balloon-assisted enteroscopy-guided radial incision of small bowel strictures under direct endoscopic visualization. Receives: Procedure: stricture incision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients not requiring additional therapeutic interventions at 1-year follow-up
Percentage of patients who do not require any new therapeutic intervention, including endoscopic balloon dilation (EBD), endoscopic stricture incision (EST), or surgery, within 1 year after the initial procedure.
Measured: 1 year
Secondary outcomes (6)
Proportion of patients not requiring additional therapeutic interventions at 3-year follow-up
Percentage of patients who do not require any new therapeutic intervention (EBD, EST, or surgery) within 3 years after the initial procedure.
Measured: 3 years
Proportion of patients not requiring additional therapeutic interventions at 5-year follow-up
Percentage of patients who do not require any new therapeutic intervention (EBD, EST, or surgery) within 5 years after the initial procedure.
Measured: 5 years
Safety assessment of the two treatment methods
Evaluation of procedure-related complications, including postoperative bleeding, perforation, and any adverse events (AEs) or serious adverse events (SAEs) occurring within 2 months after the procedure.
Measured: Within 2 months post-procedure
Immediate technical success of the procedure
Assessment of successful passage of the endoscope through the stricture immediately after balloon dilation or stricture incision.
Measured: At the time of procedure
Symptom-free duration within 1 year post-procedure
Duration of symptom-free period within 1 year after the procedure, defined as a score ≤1 on the obstruction symptom assessment scale.
Measured: 1 year
Cost analysis of the two treatment methods
Comparative analysis of medical costs associated with balloon dilation versus stricture incision, including procedure, hospitalization, and follow-up expenses.
Measured: Up to 1 year post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CD - Crohn's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yan Chen, PhD, Principal investigator, Second Affiliated Hospital of Zhejiang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07409376
- Sponsor's protocol ID
- 2025-1188
- Acronym
- CD stenosis
- Status last verified
- Dec 2025
- First submitted
- 9 Feb 2026
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No