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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
100
Nonionic contrast agent is heated to 37℃ in a incubator when injection of contrast agent
The first hospital of Lanzhou university
Lanzhou, Gansu, China
The first affiliated hospital of Xi 'an jiaotong university
Xi'an, Shaanxi, China
Tianjin Nankai Hospital
Tianjin, Tianjin Municipality, China
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
Time frame: 2 weeks
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
Time frame: During procedures
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
Time frame: 4 days
Operation time
Total time of procedure
Time frame: intraoperative
X-ray exposure time
The total time of X-ray exposure
Time frame: intraoperative
Number of participants with Post-ERCP pancreatitis
Post-ERCP pancreatitis is defined if patients experienced abdominal pain for more than 24h after ERCP, accompanying with amylase or lipase more than 3 times equal to the upper limit of normal value.
Time frame: 1 months
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