Effect of 37℃ Non-ionic Contrast Agent During ERCP Procedure in Hilar Cholangiocarcinoma

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of 37℃ Non-ionic Contrast Agent During ERCP Procedure in Hilar Cholangiocarcinoma: A Prospective Double-blind Multicenter Randomized Controlled Study

Conditions
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Cholangitis

Intervention / Treatment
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* Procedure: Injection of 37℃ contrast agent


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Injection of 37℃ contrast agent<br>Nonionic contrast agent is heated to 37℃ during ERCP when injection of contrast agent | Procedure: Injection of 37℃ contrast agent<br>* Nonionic contrast agent is heated to 37℃ in a incubator when injection of contrast agent<br>|
| No Intervention: Injection of normal contrast agent<br>Normal temperature nonionic contrast agent can be used in ERCP when injection of contrast agent | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 4 days | 
| Operation time | Total time of procedure | intraoperative | 
| X-ray exposure time | The total time of X-ray exposure | 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. | 1 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ERCP, Contrast agent, Hilar cholangiocarcinoma, Cholangitis, Nonionic