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

Hepatopancreatobiliary Surgery Institute of Gansu Province

Status

Begins enrollment in 1 month

Conditions

Cholangitis

Treatments

Procedure: Injection of 37℃ contrast agent

Study type

Interventional

Funder types

Other

Identifiers

NCT03104569

37℃ Contrast Agent in ERCP

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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