Clinical Trials in China / NCT03104569
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Effect of 37℃ Non-ionic Contrast Agent During ERCP Procedure in Hilar Cholangiocarcinoma
NCT03104569 · tracked via the Priya Life Science China tracker
Condition(s) studied
Cholangitis
Investigational drug(s) / intervention(s)
Injection of 37℃ contrast agent
Injection of 37℃ contrast agent: Nonionic contrast agent is heated to 37℃ in a incubator when injection of contrast agent
Study 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.
Eligibility
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
Primary outcome measure(s)
- 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
Trial sites (3)
| Facility | City | Region | Status |
|---|---|---|---|
| The first hospital of Lanzhou university | Lanzhou | Gansu | |
| The first affiliated hospital of Xi 'an jiaotong university | Xi'an | Shaanxi | |
| Tianjin Nankai Hospital | Tianjin | Tianjin Municipality |
More Hepatopancreatobiliary Surgery Institute of Gansu Province trials in China
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03104569 on ClinicalTrials.gov ↗ ← All trials in China