Cholangitis
Conditions
Keywords
ERCP, Contrast agent, Hilar cholangiocarcinoma, Cholangitis, Nonionic
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREInjection of 37℃ contrast agent
Nonionic contrast agent is heated to 37℃ in a incubator when injection of contrast agent
Sponsors
Hepatopancreatobiliary Surgery Institute of Gansu Province
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Type Ⅰ、Ⅱ、Ⅲ、Ⅳ of Hilar Cholangiocarcinoma; * Age: 18\ 90 years old; * Underwent diagnostic and therapeutic ERCP;
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with Acute cholangitis | 2 weeks | Acute cholangitis is defined if patients experienced abdominal pain, high fever(over 38.5℃), or chill after procedure in 2 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The ease of injection | During procedures | 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 | 4 days | 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 | intraoperative | Total time of procedure |
| X-ray exposure time | intraoperative | The total time of X-ray exposure |
| Number of participants with Post-ERCP pancreatitis | 1 months | 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. |
Countries
China
Contacts
Primary ContactWenbo Meng, M.D., Ph. D.
Backup ContactXun Li, M.D., Ph. D.
Outcome results
None listed