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Not yet recruiting NCT07409376

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

No phase Interventional CD - Crohn's Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: stricture incision, balloon dilation, No Interventions.
Who it may be relevant to
Registry conditions: CD - Crohn's Disease. Basic parameters: 16 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Procedure stricture incision
    Balloon-assisted enteroscopy-guided stricture incision versus balloon dilation
  • Procedure balloon dilation
    Balloon-assisted enteroscopy-guided balloon dilation
  • Procedure No Interventions
    No Intervention

Primary outcome measures

  • Proportion of patients not requiring additional therapeutic interventions at 1-year follow-up [Time frame: 1 year]
Secondary outcome measures (6)
  • Proportion of patients not requiring additional therapeutic interventions at 3-year follow-up [Time frame: 3 years]
  • Proportion of patients not requiring additional therapeutic interventions at 5-year follow-up [Time frame: 5 years]
  • Safety assessment of the two treatment methods [Time frame: Within 2 months post-procedure]
  • Immediate technical success of the procedure [Time frame: At the time of procedure]
  • Symptom-free duration within 1 year post-procedure [Time frame: 1 year]
  • Cost analysis of the two treatment methods [Time frame: Up to 1 year post-procedure]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07409376 · 2025-1188

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗