Epinephrine Sprayed on the Papilla for the Prevention of Post-ERCP Pancreatitis
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 670
- 试验地点
- 1
- 主要终点
- The prophylaxis effect of epinephrine sprayed on the papilla on post-ERCP pancreatitis
研究概览
简要总结
Post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) has been a well-recognized complication with significant morbidity and even mortality. A variety of possible mechanisms has been suggested in the occurrence of pancreatitis, but papillary edema caused by manipulations during cannulation or endoscopic treatment has received the most attention. The papillary edema may cause temporary outflow obstruction of pancreatic juice, and then increase ductal pressure, resulting in the occurrence of pancreatitis. Topical application of epinephrine on the papilla may reduce papillary edema. Moreover, it is reported that epinephrine sprayed on the papilla may be effective to prevent PEP. However, it is still unclear that epinephrine sprayed on the papilla can prevent acute pancreatitis after endoscopic retrograde cholangiopancreatography. We therefore designed a prospective randomized trial to determine whether epinephrine sprayed on the papilla prevent PEP after ERCP.
详细描述
Between July 2016 and December 2017, 670 consecutive patients older than 18 years who are scheduled to undergo diagnostic or therapeutic ERCP at the Anhui Provincial Hospital will be recruited for the study. Patients were randomized using opaque, sealed envelopes containing random numbers assigning them to undergo a spray of epinephrine (epinephrine group) or saline (control group) on the major papilla. A two proportion equality test will be conducted to explore whether incidence rates are different. Descriptive statistics including number (N), mean, median, standard deviation, minimum and maximum, will be produced for all continuous variables. Frequency tables of number (N) and percentage of subjects will be produced for all categorical variables.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
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
- •Males and females, age > 18 years.
- •Normal amylase level before undergoing ERCP.
- •Signed inform consent form and agreed to follow-up on time.
排除标准
- •Pregnancy or history of allergy to epinephrine.
- •Medical or psychological condition that would not permit the patient to complete the study or sign the informed consent.
- •Patients involved in other study within 60 days.
- •Billroth II or Roux-en-Y anatomy
- •Acute pancreatitis.
- •All contraindications to epinephrine.
研究组 & 干预措施
Drug: epinephrine
20-mL irrigation with epinephrine diluted to 0.02% in saline over the entire papilla
干预措施: epinephrine (Drug)
Drug: normal saline
20-mL irrigation with physiological saline over the entire papilla
干预措施: normal saline (Drug)
结局指标
主要结局
The prophylaxis effect of epinephrine sprayed on the papilla on post-ERCP pancreatitis
时间窗: PEP occurence rate at 24 h after ERCP in two groups.
If the serum amylase of patients elevation and 3 times higher than the normal values after ERCP 24 hours in high risk patients, who also have clinical symptoms, without other acute abdominal diseases,such as gastrointestinal perforation,acute cholecystitia and acute cholangitis and etc. In this condition, it will be defined PEP(post-ERCP pancreatitis). Descriptive statistics will be produced for all continuous variables. Frequency tables of number (N) and percentage of subjects will be produced for all categorical variables. Descriptive statistics will be produced for all continuous variables. Frequency tables of number (N) and percentage of subjects will be produced for all categorical variables.
次要结局
- Compare epinephrine group with control group on the incidence of hyperamylasemia/adverse events.(the incidence of hyperamylasemia/adverse events at 24 h after ERCP in two groups)