Surgery Versus Biologics for Symptomatic Stricturing Crohn's Disease : an Open-label, Single-center, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- clinical remmision rate within 1 year
研究概览
简要总结
The management of stricturing Crohn's disease (CD) remains challenging. Although surgical resection may be the final way to solve it, the efficacy of biologics for symptomatic CD associated strictures was acceptable. In clinical practice, the chioce of treatment is particularly difficult. Therefore, a clinical trial of biologics versus surgery is needed to assess which one is prefered.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •with intestinal obstructive symptoms;
- •confirmed intestinal strictures;
- •traditional drugs failed to induce remission;
- •envidence of active bowel inflammation;
- •inappropriate for EBD;
- •acquirement of written informed consent of participant;
排除标准
- •unsuccessful medical treatment of intestinal obstruction;
- •complete obstruction;
- •contraindication for biologics;
- •penetrating disease;
- •short smaal bowel;
- •suspicion of bowel tumor;
- •no confirmed strictures;
- •comitant severe disese of other system;
- •obstructive symptoms under over 2 targets of biologics;
- •successful treatment with traditional drugs;
- •participate other clinical research.
研究组 & 干预措施
Surgery group
treat paticipants with surgery and prophylactic medication according to the guidelines
干预措施: Group B (Procedure)
Biologic group
If biologic(s) fails to provide relief, surgical intervention is considered. Following surgery, a prophylactic medication is offered based on the risk factors for recurrence
干预措施: Group A (Drug)
结局指标
主要结局
clinical remmision rate within 1 year
时间窗: within 1 year
Crohn's disease activity index \< 150
次要结局
- clinical remmision rate within 5 year(within 5 year)
- medical cost(within 1 and 5 year)
- sugical recurrence(within 1 and 5 year)
- inflammatory bowel disease score(within 1 and 5 year)
- Crohn's disease obstructive score(within 1 and 5 year)
- endoscopic recurrence(within 1 and 5 year)
研究者
Zhu Weiming
chief of general surgery
Jinling Hospital, China