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

  • STATUS
    Recruiting
  • End date
    Apr 1, 2023
  • participants needed
    100
  • sponsor
    Hepatopancreatobiliary Surgery Institute of Gansu Province
Updated on 25 November 2021

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.

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.

Details
Condition Cholangitis
Treatment Injection of 37℃ contrast agent
Clinical Study IdentifierNCT03104569
SponsorHepatopancreatobiliary Surgery Institute of Gansu Province
Last Modified on25 November 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Type 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 and a history of cholangioenterostomy including cholangio-jejunostomy and side to side anastomosis of the bile duct and duodenum
Previous ERCP
Pregnant women
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