Comparative Prospective Multicenter Randomized Study of Endoscopic Treatment of Stenosis in Crohn´s Disease: Metal Self-expanding Prosthesis Balloon Dilatation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 122
- 试验地点
- 2
- 主要终点
- Percentage (%) of free patients of therapeutic intervention (dilatation, prosthesis or surgery) for symptomatic recurrence at one year follow-up
研究概览
简要总结
This study will be a multicentre randomized controlled trial to assess the efficacy between balloon dilatation and self-expanding metallic stent placement for endoscopic treatment of stenosis in Crohn´s Disease.
详细描述
A Prospective, randomized, multicenter clinical trial.
Duration: Beginning in mid-2013 with a minimum of three years depending on the patient inclusion rate.
The participation of at least 20 hospitals in Spain with an inclusion of about 6 patients per hospital is required.
Calculation of sample size: The calculation of sample size was performed considering that the efficacy of endoscopic treatment by endoscopic stent placement is superior to endoscopic dilatation: 75% vs 50% for balloon dilation (% of patients free of therapeutic intervention -endoscopic or surgically a year follow-up).
For all 61 patients are required for each treatment group, the total of 122 patients. This calculation is made taking into account:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 years.
- •Crohn's Disease with a predominantly fibrotic stenosis de novo and / or post- surgical confirmed by endoscopic and radiological tests, accessible by endoscopy (colonoscopy).
- •Patients with stenosis already known and previously treated with stent and / or dilation with> 1 Year asymptomatic
- •Symptoms of intestinal partial occlusion
- •Refractory to Conventional medical treatment (no response to usual therapeutic range "accelerated step-up").
- •Length of stenosis <10 cm.
- •Submit a maximum of 2 stenosis.
- •Patient Informed consent
排除标准
- •No patient Informed consent.
- •Stenosis complicated with abscess, fistula or important activity associated with your EC not limited to the stenosis area.
- •Patients with stenosis already known and previously treated with stent and / or dilation with <1 year asymptomatic.
- •Pregnancy and lactation
- •Any clinical situation that prevents the performance of endoscopy
- •Stenosis not accessible by endoscopy
- •Asymptomatic patient
- •Length of stenosis ≥ 10 cm.
- •Submit> 2 stenosis.
- •Severe coagulation disorders (platelets <70000; INR> 1.8)
结局指标
主要结局
Percentage (%) of free patients of therapeutic intervention (dilatation, prosthesis or surgery) for symptomatic recurrence at one year follow-up
时间窗: one year follow-up
To evaluate the efficacy of endoscopic treatment (prosthesis vs dilation), determined by the percentage of free patients of a new therapeutic intervention (dilatation, prosthesis or surgery) for symptomatic recurrence at one year follow-up. Symptomatic recurrence assessment: It will be performed through an obstructive symptoms scale previously described (Attar et al, Safety and efficacy of extractible self-expandable metal stents in the treatment of Crohn's disease intestinal strictures: A prospective pilot study. Inflamm Bowel Dis. 2011 Dec 11).
次要结局
- The procedure total costs(one year follow-up)
- Percentage of free patients of therapeutic intervention (dilatation, prosthesis or surgery) for symptomatic recurrence at 6 months follow-up.(At 6 months follow-up)
- Rate of complications related to the procedure.(one year follow-up)