Effect of 37℃ Non-ionic Contrast Agent During ERCP Procedure in Hilar Cholangiocarcinoma: A Prospective Double-blind Multicenter Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 6
- 主要终点
- Number of participants with Acute cholangitis
研究概览
简要总结
The purpose of this study is to determine the effect of normal temperature and 37℃ non-ionic contrast agent acting on ERCP-related cholangeitis after endoscopic retrograde cholangiopancreatography (ERCP) in the treatment of hilar cholangiocarcinoma.
详细描述
At present, the common used contrast agent in ERCP is composed of ionic and non-ionic type, and the latter's advantages lie in its slighter toxic-and-side effect and favorable security. When heated to 37℃, the 20 ℃ contrast agents would be diluted to 50% consistency, then a shorter time period of its intravascular and other intracavitary stay would add to less cell damage. And the applications of heated non-ionic contrast agents could be found in computed tomography angiography(CTA), hysterosalpingography (HSG) and cystourethrography, and consequently the patients with the intervention of heated non-ionic contrast agents felt more comfortable and fewer adverse reactions could be observed. Nevertheless, heated contrast agent was rarely reported to act in ERCP. It's theoretically possible that its heat-reduced lower mucosity could help the contrast agent itself to drainage, so that the incidence of cholangeitis could be under control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type Ⅰ、Ⅱ、Ⅲ、Ⅳ of Hilar Cholangiocarcinoma;
- •Age: 18~90 years old;
- •Underwent diagnostic and therapeutic ERCP;
排除标准
- •Coagulation dysfunction(INR>1.3) or/and low peripheral blood platelet count （PLT <50x10^9/L）;
- •Preoperative acute cholangitis;
- •Preoperative acute pancreatitis;
- •Preoperative hemobilia or hemorrhage of digestive tract;
- •Preoperative liver failure;
- •Combined with Mirizzi syndrome and intrahepatic bile duct stones;
- •Preoperative malignant tumor of biliary system such as carcinoma of head of pancreas, gallbladder carcinoma;
- •Biliary-duodenal fistula confirmed during ERCP;
- •A history of reconstructive surgery for upper digestive tract except Billroth Ⅰand a history of cholangioenterostomy including cholangio-jejunostomy and side to side anastomosis of the bile duct and duodenum;
- •Previous ERCP;
- •Pregnant women
结局指标
主要结局
Number of participants with Acute cholangitis
时间窗: 2 weeks
Acute cholangitis is defined if patients experienced abdominal pain, high fever(over 38.5℃), or chill after procedure in 2 weeks
次要结局
- The ease of injection(During procedures)
- Number of Participants With Abnormal Laboratory Values(4 days)
- Number of participants with Post-ERCP pancreatitis(1 months)
- X-ray exposure time(intraoperative)
- Operation time(intraoperative)
研究者
Xun Li
M.D., Ph. D, Director.
Hepatopancreatobiliary Surgery Institute of Gansu Province