Endoscopic Papillary Short Duration Large Balloon Dilatation for Removal of Large Bile Duct Stones: a Prospective Multicenter Study of Short and Long-term Adverse Events
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- Rate of bleeding
研究概览
简要总结
ESGE guidelines suggests 30-60 seconds endoscopic large balloon papillary dilation from the disappearance of the waist of the papilla.
The investigators have good results in stone removal with much quicker dilatations when the cholangiogram is followed and the dilation is finished as soon as the disappearance of the waist of the papilla is seen. This Scandinavian multicenter prospective study is especially interested in stone clearance rate and short and long-term adverse events such as pancreatitis, cholangitis, bleeding, perforations, residual biliary stones, and newly developing biliary stones.
详细描述
This study is planned as a multicenter Scandinavian prospective study including all the patients >18 years with >10mm diameter common bile duct stones visible in cholangiogram. Before ERCP all patient will be informed about this trial, and if they agree to participate this study, they need to give a written informed consent. The endoscopists will decide whether the first step will be large EST and stone extraction or small EST and dilatation. If simple EST does not success, the dilatation will remain as a rescue method. The diameter of dilatation balloon cannot exceed the diameter of common bile duct above the papilla. Cholangiogram is followed when papilla is dilated and the dilatation will be ended when the waist of the papilla disappears. The duration of the dilatation measured, but it does not define the ending of dilatation. All adverse events will be recorded one month and a year after the procedure.
Classification of the patients:
- EST and stone extraction
- EPLBD when EST and stone extraction did not succeed
- Short EST and EPLBD
The investigators will collect the information of adverse events such as bleeding, pancreatitis, cholangitis with patient questionnaire as well as from the patient records one month and a year after the procedure
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 years
- •Common bile duct stone >10mm diameter
排除标准
- •Altered anatomy after surgery (B II, Roux-en-Y reconstruction)
- •Common bile duct cysts
- •Acute pancreatitis
- •Distal common bile duct stricture or tumor
- •Coagulation disorders
- •Ongoing coagulation medication
- •Pregnancy
- •Inability to give an informed consent
结局指标
主要结局
Rate of bleeding
时间窗: 30 days
need for additional intervention or need for blood transfusion and hemoglobin drop more than 2 gm/dL
Rate of cholangitis
时间窗: 30 days
Fever \>38
Rate of pancreatitis
时间窗: 30 days
Plasma amylase rises \>3 times the upper limit and newly developed stomach ace more than 24h
次要结局
未报告次要终点
研究者
Mia Rainio
Principal Investigator
Helsinki University Central Hospital