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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- Proportion of patients not requiring additional therapeutic interventions at 1-year follow-up
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
No Intervention
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.
干预措施: No Interventions (Procedure)
Balloon-assisted enteroscopy-guided balloon dilation
Patients in this arm will undergo balloon dilation of small bowel strictures under balloon-assisted enteroscopy to relieve luminal narrowing.
干预措施: balloon dilation (Procedure)
Balloon-assisted enteroscopy-guided stricture incision
Patients in this arm will receive balloon-assisted enteroscopy-guided radial incision of small bowel strictures under direct endoscopic visualization.
干预措施: stricture incision (Procedure)
结局指标
主要结局
Proportion of patients not requiring additional therapeutic interventions at 1-year follow-up
时间窗: 1 year
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.
次要结局
- Immediate technical success of the procedure(At the time of procedure)
- Symptom-free duration within 1 year post-procedure(1 year)
- Proportion of patients not requiring additional therapeutic interventions at 3-year follow-up(3 years)
- Proportion of patients not requiring additional therapeutic interventions at 5-year follow-up(5 years)
- Safety assessment of the two treatment methods(Within 2 months post-procedure)
- Cost analysis of the two treatment methods(Up to 1 year post-procedure)