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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Effect of 37℃ Non-ionic Contrast Agent During ERCP Procedure in Hilar Cholangiocarcinoma: A Prospective Double-blind Multicenter Randomized Controlled Study

Brief 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.

Detailed Summary: 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.
Sponsor: Hepatopancreatobiliary Surgery Institute of Gansu Province

Current Primary Outcome: Number of participants with Acute cholangitis [ Time Frame: 2 weeks ]

Acute cholangitis is defined if patients experienced abdominal pain, high fever(over 38.5℃), or chill after procedure in 2 weeks


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • The ease of injection [ Time Frame: During procedures ]
    The ease of contrast agent injection has been considered by ERCP assistant, a questionnaire is required to assign by the assistant
  • Number of Participants With Abnormal Laboratory Values [ Time Frame: 4 days ]
    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
  • Operation time [ Time Frame: intraoperative ]
    Total time of procedure
  • X-ray exposure time [ Time Frame: intraoperative ]
    The total time of X-ray exposure
  • Number of participants with Post-ERCP pancreatitis [ Time Frame: 1 months ]
    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.


Original Secondary Outcome: Same as current

Information By: Hepatopancreatobiliary Surgery Institute of Gansu Province

Dates:
Date Received: March 26, 2017
Date Started: May 1, 2017
Date Completion: April 1, 2018
Last Updated: April 3, 2017
Last Verified: April 2017