About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Type Ⅰ、Ⅱ、Ⅲ、Ⅳ of Hilar Cholangiocarcinoma;
Age: 18~90 years old;
Underwent diagnostic and therapeutic ERCP;
Disqualifiers
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;
Trial design
Parallel
Treatments tested in this trial
Injection of 37℃ contrast agent
Procedure/SurgeryNonionic contrast agent is heated to 37℃ in a incubator when injection of contrast agent
Treatment groups
Trial outcomes
Primary outcomes
Number of participants with Acute cholangitis
Acute cholangitis is defined if patients experienced abdominal pain, high fever(over 38.5℃), or chill after procedure in 2 weeks
Secondary outcomes
The ease of injection
The ease of contrast agent injection has been considered by ERCP assistant, a questionnaire is required to assign by the assistant
Number of Participants With Abnormal Laboratory Values
9 parameter will be collected in day 2 and day 4 after procedures. Abnormal in Total bilirubin (TBIL), White Blood Count (WBC), N%,Platelet( PLT), Procalcitonin(PCT) or C-reactive protein(CRP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), and Gamma - glutamyl transpeptidase (GGT) required to be documented
Operation time
Total time of procedure
X-ray exposure time
The total time of X-ray exposure
Sponsors and contacts
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