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NCT03104569Not yet recruiting

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

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

Source: ClinicalTrials.gov · Last updated 26 Dec 2025

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
100 (estimated)
First submitted
26 Mar 2017
Start date
1 Apr 2026
Primary completion date
1 Dec 2028
Lead sponsor
Hepatopancreatobiliary Surgery Institute of Gansu Province
NCT number
NCT03104569

What you commit to

  • Study type: Interventional
  • Planned participants: 100
  • From 1 Apr 2026 to the primary completion date, 1 Dec 2028
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous ERCP;

Other illness

  • 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;

Lab values

  • Coagulation dysfunction(INR\>1.3) or/and low peripheral blood platelet count (PLT \<50x10\^9/L);

Other

  • Preoperative acute cholangitis;
  • Preoperative acute pancreatitis;
  • Pregnant women

Who the study is looking for

  • Type Ⅰ、Ⅱ、Ⅲ、Ⅳ of Hilar Cholangiocarcinoma;
  • Age: 18\~90 years old;
  • Underwent diagnostic and therapeutic ERCP;

Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The First Hospital of Lanzhou University
Coordinator of this site? Confirm its status
LanzhouChinaUnknown status
Tianjin Nankai Hospital
Coordinator of this site? Confirm its status
TianjinChinaUnknown status
The First Affiliated Hospital of Xi'an Jiaotong University
Coordinator of this site? Confirm its status
Xi’anChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.