Efficacy and Safety of Endoscopic Balloon Dilatation Combined With Autologous Platelet-rich Plasma (PRP) Injection in Colonic Stenosis in Crohn's Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- restenosis rate
研究概览
简要总结
The aim was to investigate whether endoscopic balloon dilatation combined with PRP injection can help prevent or prolong restenosis in patients with Crohn's disease with colonic stenosis, and to explore the concentration of PRP. The study was a single-center, randomized, non-controlled study. Experimental group of patients underwent endoscopic balloon dilation and submucosal injection of PRP (PRP prepared by the blood transfusion department of our hospital) at the wound edge, historical control was used, and the patients included in the study were randomly divided into high concentration group and low concentration group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed as CD;
- •Stenosis of the colon was found during colonoscopy, and surgery was not considered for the time being; ③ Imaging stenosis was found, that is, CTE suggested stenosis with proximal intestinal dilatation >3cm;
- •Narrow length <5cm; ⑤ The patients agreed to undergo endoscopic balloon dilatation and voluntarily signed the informed consent to participate in this study, and were capable of complying with the agreement.
排除标准
- •The patient has contraindications for endoscopic therapy, such as coagulation disorder, severe cardiopulmonary dysfunction, active bleeding, and inability to cooperate.
- •Deep and large active ulcer was found in the stenosis;
- •< 18 years old;
- •④ Foreign patients;
- •⑤ Patients with a history of malignant tumors, including melanoma (except local skin cancer);
- •⑥ Pregnant or nursing patients;
- •⑦ Patients who could not be followed at all nodes of the primary outcome indicator; Other diseases that researchers believe could put patients at risk;
- •⑧ Other diseases that researchers believe could put patients at risk.
结局指标
主要结局
restenosis rate
时间窗: 3 months after endotherapy
restenosis means the endoscopy with size of 10.5mm can not pass the stricture afer endotherapy
次要结局
- Changes in intestinal ultrasound(3 months after endotherapy)
- Proportion of surgery(1 year after endotherapy)
研究者
Yi Lu
doctor
Sixth Affiliated Hospital, Sun Yat-sen University