Multinational Study on Endoscopic Management of Distal Malignant Biliary Obstruction Combined With Gastric Outlet Obstruction
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 25
- 主要终点
- Time to recurrent biliary obstruction
研究概览
简要总结
This is a retrospective study to evaluate the outcomes of endoscopic biliary drainage according to the timing of distal malignant biliary obstruction (MBO) in relation to gastric outlet obstruction (GOO) and the location of GOO.
详细描述
This is a multinational multicenter retrospective cohort study to evaluate the outcomes of endoscopic biliary drainage in patients with a duodenal SEMS. Endoscopic ultrasound-guided biliary drainage (EUS-BD), including choledochoduodenostomy, hepaticogastrostomy, antegrade biliary stenting or a combination, and endoscopic retrograde cholangiopancreatography (ERCP) with stenting are to be compared. Specifically, the outcomes are to be evaluated according to the timing of distal MBO in relation to GOO and the location of GOO.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who underwent endoscopic placement of a duodenal SEMS for nonresectable malignant GOO.
- •Patients who underwent endoscopic biliary drainage for nonresectable MBO.
- •MBO was located ≥ 2 cm from the bifurcation.
- •Patients who could be followed up more than three months after completion of both biliary drainage and duodenal SEMS placement.
- •Age ≥20 years.
- •Irrespective of sex and a primary disease.
排除标准
- •Patients who underwent surgical bypass for GOO.
- •Patients who underwent percutaneous and surgical biliary drainage prior to the placement of duodenal SEMS.
- •Patients with altered gastrointestinal anatomy (Billroth-II reconstruction, Roux-en-Y reconstruction, etc.).
- •Patients who would not give a consent to the report of their own data.
- •Patients considered ineligible for inclusion in the study by an investigator for other reasons.
结局指标
主要结局
Time to recurrent biliary obstruction
时间窗: Up to 1 year
Recurrent biliary obstruction is defined as a composite endpoint of either occlusion or migration of biliary stent, and time to recurrent biliary obstruction is time from biliary drainage to recurrence of biliary obstruction.
次要结局
- Functional success rate of biliary drainage(2 weeks)
- Survival time(Up to 2 year)
- Causes of recurrent biliary obstruction(Up to 1 year)
- Procedure-related complication of biliary drainage and duodenal meta stent placement (type and severity)(30 days)
研究者
Hiroyuki Isayama, MD, PhD
Associate Professor
Tokyo University