Long-term Follow-up ProtDilat Study; Comparative Prospective Multicenter Randomized Study of Endoscopic Treatment of Stenosis in Crohn´s Disease: Self-expandable Metal Stent vs. Endoscopic Balloon Dilatation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Percentage of surgery-free patients post-treatment
研究概览
简要总结
Stenosis is one of the most frequent complications in patients with Crohn's disease (CD), causing greater morbidity and increasing the probability of repeated surgery and short bowel syndrome. Several endoscopic techniques, as an alternative to surgery, have been used in the treatment of fibrostenotic CD, with similar efficacy and lower risk of complications.
The ProtDilat study (NCT02395354) showed that both endoscopic balloon dilation (EBD) and self-expandable metal stents (SEMS) are efficient and safe for the treatment of stenosis in CD, while EBD shows therapeutic superiority (80.5 vs 51.3 %) at one year follow-up. However, this difference was not observed in the subanalysis of patients with stenosis > 3 cm (EBD: 66.7% vs SEMS: 63.6%) but with a lower cost for EBD (EDB 1,365.63 euros versus SEMS 1,923.55 euros).
Therefore, SEMS could be a suitable treatment option for longer stenoses in which EBD has proven to be less efficacious. Moreover, the long-term efficacy of both endoscopic treatments is still debated with scare information and without data from a clinical trial.
The aim of this study is to assess the long-term efficacy of EBD and SEMS, through the follow-up of the patients included in the ProtDilat study, being the primary objective of the study the percentage of patients free of surgical intervention at the end of follow-up. Retrospective study based on data from the ProtDilat trial (patients with CD, obstructive symptoms, with stenosis < 10cm). Data on medical, endoscopic and surgical treatment and smoking habits are collected.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •CD with predominating de novo and/or anastomotic fibrotic stenosis confirmed by endoscopy and radiology and accessible by endoscopy (colonoscopy).
- •Stenosis previously treated with a stent and/or dilatation and with at least one year asymptomatic.
- •Intestinal occlusion or sub-occlusion symptomatology.
- •Refractoriness to conventional medical treatment (no response to accelerated step-up of normal therapeutic scale).
- •Stenosis length < 10 cm.
- •Maximum 2 stenoses.
- •Informed consent of patient.
排除标准
- •No informed consent of patient.
- •Stenosis complicated by abscess, fistula, or important activity associated with CD not limited to the stenosis area.
- •Stenosis previously treated with a stent and/or dilatation and with less than one year asymptomatic.
- •Pregnancy or lactation.
- •Any clinical condition that prevents the performance of endoscopy.
- •Stenosis inaccessible by colonoscopy.
- •No obstructive symptoms.
- •Stenosis length ≥ 10 cm.
- •Presenting more than 2 stenoses.
- •Serious coagulation disorder (platelets < 70000; INR > 1.5)
结局指标
主要结局
Percentage of surgery-free patients post-treatment
时间窗: end of long-term follow up (median 7 years post-treatment)
次要结局
- Long-term effectiveness of endoscopic treatment (SEMS vs EBD): percentage of patients free of surgery and who have not required any endoscopic retreatment(end of long-term follow up (median 7 years post-treatment))
- Percentage of patients with safety issues and/or complications related to endoscopic or surgical treatment(end of long-term follow up (median 7 years post-treatment))
- Percentage of patients that have not required any endoscopic retreatment(end of long-term follow up (median 7 years post-treatment))