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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Proportion of patients not requiring additional therapeutic interventions at 1-year follow-up [Срок оценки: 1 year]

Вторичные конечные точки (6)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07409376 · 2025-1188

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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