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

No phase Interventional Cholangitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Injection of 37℃ contrast agent.
Who it may be relevant to
Registry conditions: Cholangitis. Basic parameters: 18 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
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Official title

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

Overview

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 description

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.

Interventions

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

Primary outcome measures

  • Number of participants with Acute cholangitis [Time frame: 2 weeks]
Secondary outcome measures (5)
  • The ease of injection [Time frame: During procedures]
  • Number of Participants With Abnormal Laboratory Values [Time frame: 4 days]
  • Operation time [Time frame: intraoperative]
  • X-ray exposure time [Time frame: intraoperative]
  • Number of participants with Post-ERCP pancreatitis [Time frame: 1 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

China · 3 centers
  • The first hospital of Lanzhou university — Lanzhou
  • The first affiliated hospital of Xi 'an jiaotong university — Xi'an
  • Tianjin Nankai Hospital — Tianjin

Identifiers

NCT: NCT03104569 · 37℃ Contrast Agent in ERCP

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗