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

Cholangitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03104569
• Other study ID #: 37? Contrast Agent in ERCP
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: December 1, 2025

Study information

• Verified date: January 2024
• Source: Hepatopancreatobiliary Surgery Institute of Gansu Province
• Contact: Wenbo Meng, M.D., Ph. D.
• Phone: +8613919177177
• Email: mengwb[@]lzu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Type ??????? 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 ?and a history of cholangioenterostomy including cholangio-jejunostomy and side to side anastomosis of the bile duct and duodenum;

• Previous ERCP;

• Pregnant women

Related Conditions & MeSH terms

• Cholangiocarcinoma
• Cholangitis
• Klatskin Tumor

Intervention

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

Locations

Country	Name	City	State
China	The first hospital of Lanzhou university	Lanzhou	Gansu
China	Tianjin Nankai Hospital	Tianjin	Tianjin
China	The first affiliated hospital of Xi 'an jiaotong university	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Hepatopancreatobiliary Surgery Institute of Gansu Province

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	2 weeks
Secondary	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	During procedures
Secondary	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	4 days
Secondary	Operation time	Total time of procedure	intraoperative
Secondary	X-ray exposure time	The total time of X-ray exposure	intraoperative
Secondary	Number of participants with Post-ERCP pancreatitis	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.	1 months