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.
82 studies on the registry are indexed under Cholangitis; 17 are open to participants now.
This study's planned enrollment of 100 is close to the median of 100 across 52 interventional studies indexed under Cholangitis.
Browse Cholangitis studies →Hepatopancreatobiliary Surgery Institute of Gansu Province is the lead sponsor of 44 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Start is estimated for Apr 2026; primary completion for Dec 2028, 32 months later.
Of 21 interventional studies with no phase under Cholangitis, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 68. This study's planned 32 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Hepatopancreatobiliary Surgery Institute of Gansu Province