An interventional study of Injection of 37℃ contrast agent in Cholangitis, sponsored by Hepatopancreatobiliary Surgery Institute of Gansu Province. Not yet recruiting at 3 sites in China. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-12-26.
Sponsored by Hepatopancreatobiliary Surgery Institute of Gansu Province · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Nonionic contrast agent is heated to 37℃ during ERCP when injection of contrast agent
Procedure: Injection of 37℃ contrast agent
Normal temperature nonionic contrast agent can be used in ERCP when injection of contrast agent
Nonionic contrast agent is heated to 37℃ in a incubator when injection of contrast agent
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
Time frame: 2 weeks
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
Time frame: 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
Time frame: 4 days
Operation time
Total time of procedure
Time frame: intraoperative
X-ray exposure time
The total time of X-ray exposure
Time frame: 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.
Time frame: 1 months
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hepatopancreatobiliary Surgery Institute of Gansu Province