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NCT Number: NCT03104569

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

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The first hospital of Lanzhou university, Lanzhou, Gansu, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Injection of 37℃ contrast agent

Procedure

Nonionic contrast agent is heated to 37℃ in a incubator when injection of contrast agent

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. Operation time

    Time frame: intraoperative

    Total time of procedure

  4. X-ray exposure time

    Time frame: intraoperative

    The total time of X-ray exposure

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Wenbo Meng, M.D., Ph. D.

CONTACT

[email protected]

+8613919177177

Xun Li, M.D., Ph. D.

CONTACT

[email protected]

+8613993138612

Sponsors and collaborators

Lead sponsor

Hepatopancreatobiliary Surgery Institute of Gansu Province

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 7, 2017
Registry last updated
Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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