Effect of Predictive Model on Total Double-Balloon Enteroscopy Rate: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 338
- 试验地点
- 5
- 主要终点
- Total enteroscopy rate
研究概览
简要总结
The aim of this study is to assess the effect of predictive model on total enteroscopy rate in double-balloon enteroscopy.
详细描述
Double-balloon enteroscopy is a new and effective endoscopic technique used for the diagnosis and treatment of small intestinal diseases. Due to its deep intubation ability, it can achieve complete visualization of the small intestinal mucosa, that is, total enteroscopy. Theoretically, a higher total enteroscopy rate could be associated with a greater possibility of detecting positive lesions. However, a total enteroscopy is a challenging procedure for endoscopists. Endoscopists cannot accurately predict the operational difficulty of patients before the operation, which leads to the passivity of preoperative preparation and intraoperative strategy formulation.
Recently, the Department of Gastroenterology of Qilu Hospital of Shandong University has completed the development and external validation of the first double-balloon enteroscopy prediction model. A preoperative individualized assessment of the difficulty of total enteroscopy can be achieved using this model. Therefore, a multicenter randomized controlled study was designed to assess the performance of predictive model in double-balloon enteroscopy, including total enteroscopy rate, positive findings, procedural time, adverse events and other indicators.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients aged between 18 and 80 years who were planned to undergo an attempt at total enteroscopy for suspected small-bowel disease
- •CT scan of the abdomen was performed within two weeks before enteroscopy
排除标准
- •cases terminated upon the target lesion (strictures, masses, hemorrhagic or other lesions) and not the maximal insertion
- •poor quality of bowel preparation
- •high risk esophageal varices
- •the insertion route is not oral or anal because of changes in anatomical structure
- •unsuitable for general anesthesia
- •pregnant women
- •unable to provide informed consent
研究组 & 干预措施
Predictive model group
Endoscopists will obtain the predictive model intervention.
干预措施: Predictive model (Other)
Control group
Endoscopists will not obtain the predictive model intervention.
结局指标
主要结局
Total enteroscopy rate
时间窗: 8 months
Total enteroscopy rate was defined as the number of patients with complete visualization of the small bowel divided by the total number of patients.
次要结局
- Diagnostic yield(8 months)
- Procedural time(8 months)
- Adverse events(8 months)
研究者
Xiuli Zuo
Director of the Qilu Hospital Gastroenterology Department
Qilu Hospital of Shandong University