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临床试验/NCT03756116
NCT03756116Unknown不适用

Effect of Papillary Epinephrine Spraying for the Prevention of Post-ERCP Pancreatitis in Patients Received Sublingual Nitroglycerin: A Multi-center, Single-blind, Randomized Controlled Trial

The Second Hospital of Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2018年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
2,000
试验地点
1
主要终点
Incidence of post-ERCP pancreatitis in the groups

研究概览

简要总结

Post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) is the most common complication with high costs, significant morbidity and even mortality. The major mechanisms of PEP is the papillary edema which is caused by manipulations during cannulation or endoscopic treatment. The papillary edema may cause temporary outflow obstruction of pancreatic juice, and then increase ductal pressure, resulting in the occurrence of pancreatitis. Nitroglycerin can reduce the Oddis sphincter tension, the internal pressure of the biliary tract and the pancreatic duct. Therefore, it is widely used in clinical to prevent and treat pancreatitis. Many studies found nitroglycerin might be effective in preventing PEP. And topical application of epinephrine on the papilla may reduce papillary edema by decreasing capillary permeability or by relaxing the sphincter of Oddi. There are reports that epinephrine sprayed on the papilla may be effective to prevent PEP.

The investigators therefore designed a prospective randomized trial to determine whether routine using papillary epinephrine spraying in patients received octreotide can reduce post-ERCP pancreatitis.

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
None

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

入选标准

  • ERCP surgery is required
  • Signed inform consent form and agreed to follow-up on time.

排除标准

  • Acute pancreatitis.
  • Pregnancy or history of allergy to epinephrine.
  • Serious liver, kidney, heart and coagulation disorders
  • Unwilling or inability to provide consent

研究组 & 干预措施

Epinephrine sprayed on the papilla

Experimental

Patients received sublingual Nitroglycerin will receive 20 ml of 0.02% epinephrine sprayed on the duodenal papilla before the withdrawal of endoscope.

干预措施: Epinephrine sprayed on the papilla (Procedure)

Saline sprayed on the papilla

Active Comparator

Patients received sublingual Nitroglycerin will receive 20 ml of normal saline sprayed on the duodenal papilla before the withdrawal of endoscope; followed by octreotide.

干预措施: Saline sprayed on the papilla (Procedure)

结局指标

主要结局

Incidence of post-ERCP pancreatitis in the groups

时间窗: 48 hours after ERCP

The primary outcome is the incidence of PEP as defined by the consensus guidelines as 1) New or increased abdominal pain that is clinically consistent with a syndrome of acute pancreatitis without other acute abdominal diseases,such as gastrointestinal perforation,acute cholecystitia and acute cholangitis and etc, and 2) amylase or lipase ≥ 3x the upper limit of normal 48 hours after the procedure.

次要结局

  • Others complications(1 weeks after ERCP)

研究者

发起方
The Second Hospital of Nanjing Medical University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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