The Association Between Post-ERCP Acute Pancreatitis and Various Genetic Mutations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Post-ERCP pancreatitis
研究概览
简要总结
Pancreatitis remains the most common complication of ERCP, with the reported incidence ranging from 2% to 9%. Although 80% of cases are mild, a significant number of patients may develop severe pancreatitis, that means additional morbidity and risk for death. ERCP, despite the development of new diagnostic tools, remains a widely used procedure, so post-ERCP pancreatitis is a problem with significant impact. Several studies and meta-analyses helped us to recognize special factors that put an individual in high risk for the development of post-ERCP pancreatitis. Among these factors special interest presents the history of post-ERCP pancreatitis as an independent risk factor for a new episode of post-ERCP pancreatitis. It seems that some individuals have a genetically predisposed susceptibility in this particular complication. The aim of the present study is to investigate the possible genetic variation associated with post-ERCP pancreatitis using whole genome sequencing.
详细描述
This study includes patients who are at high risk of post-ERCP pancreatitis. Blood samples will be gathered to investigate the possible genetic variation associated with post-ERCP pancreatitis using whole genome sequencing. DNA for whole genome sequencing will be extracted using DNA extraction kit (Qiagen Inc., Hinden, Germany) and the concentration & purity of DNA will be measured using Nanodrop (Nano Drop Technologies, Wilmington, DE, USA) or fluorometric quantitation(Qubit fluorometer). Genetic variations which are associated with acute pancreatitis will be searched using whole genome sequencing. Post-ERCP pancreatitis is the primary outcome. Medical records and data of genetic variations will be reviewed for identifying possible risk factors and genetic variations associated with post-ERCP pancreatitis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients who undergo ERCP with high risk factors of post-ERCP pancreatitis
排除标准
- •<18 years old
- •current pancreatitis (<72hrs before ERCP)
- •pregnant woman, breast-feeding woman
- •patient refusal
- •contraindication of ERCP
- •patients who would only be treated of bile duct such as a change of stent with previous endoscopic sphincterotomy
- •chronic pancreatitis
- •patients who underwent gastrectomy (Billroth II or Roux-en Y anastomosis)
- •patients who have pancreatic or distal bile duct cancer
结局指标
主要结局
Post-ERCP pancreatitis
时间窗: 24 hours after ERCP
Clinical pancreatitis, amylase at least 3 x normal \>24h after ERCP
次要结局
- Severe post-ERCP pancreatitis(24 hours after ERCP)
- Length of stay(3mo)
- hyperamylasemia without symptom(24 hours after ERCP)
- Mortality(3mo)
研究者
Sang Hyub Lee
Professor
Seoul National University Hospital