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

ConditionCholangitis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorHepatopancreatobiliary Surgery Institute of Gansu Province

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Type Ⅰ、Ⅱ、Ⅲ、Ⅳ of Hilar Cholangiocarcinoma;

Age: 18~90 years old;

Underwent diagnostic and therapeutic ERCP;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Injection of 37℃ contrast agent

    Procedure/Surgery

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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Injection of 37℃ contrast agentExperimental treatment 1 intervention
Group B: Injection of normal contrast agentNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

Operation time

Total time of procedure

Time frame
intraoperative
4

X-ray exposure time

The total time of X-ray exposure

Time frame
intraoperative

Other outcomes

Sponsors and contacts

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