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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cholangitis
• Intervention / Treatment: Procedure: Injection of 37℃ contrast agent

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xun Li, M.D., Ph. D.; Phone Number: +8613993138612; Email: drlixun@163.com
• Study Contact Backup: Name: Wenbo Meng, M.D., Ph. D.; Phone Number: +8613919177177; Email: mengwb@lzu.edu.cn

Study Locations

• China
  • Gansu
    • Lanzhou, Gansu, China, 730000
      • The First Hospital of Lanzhou University
      • Contact: Wence Zhou, M. D.; Phone Number: +8609318356919; Email: zhouwc129@163.com
      • Contact: Wenbo Meng, M. D.; Phone Number: +8609318356213; Email: mengwb@lzu.edu.cn
  • Shaanxi
    • Xi'an, Shaanxi, China, 710061
      • The First Affiliated Hospital of Xi 'an Jiaotong University
      • Contact: Hao Sun, M. D.; Phone Number: +86 13891813691; Email: sunhaoxjfy@126.com
  • Tianjin
    • Tianjin, Tianjin, China, 300100
      • Tianjin Nankai Hospital
      • Contact: Zhenyu Wang, M. D.; Phone Number: +86 15302021661; Email: Wangzytj@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Injection of 37℃ contrast agent; Nonionic contrast agent is heated to 37℃ during ERCP when injection of contrast agent	Procedure: Injection of 37℃ contrast agent; Nonionic contrast agent is heated to 37℃ in a incubator when injection of contrast agent
No Intervention: Injection of normal contrast agent; Normal temperature nonionic contrast agent can be used in ERCP when injection of contrast agent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Operation time	Total time of procedure	intraoperative
X-ray exposure time	The total time of X-ray exposure	intraoperative
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

Collaborators and Investigators

• Sponsor: Hepatopancreatobiliary Surgery Institute of Gansu Province
• Investigators: Study Chair: Xun Li, M.D., Ph. D., Hepatopancreatobiliary Surgery Institute of Gansu Province

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: March 26, 2017
• First Submitted That Met QC Criteria: April 3, 2017
• First Posted (Actual): April 7, 2017

Study Record Updates

• Last Update Posted (Actual): January 11, 2024
• Last Update Submitted That Met QC Criteria: January 9, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: ERCP; Cholangitis; Hilar cholangiocarcinoma; Contrast agent; Nonionic
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Biliary Tract Diseases; Bile Duct Diseases; Cholangiocarcinoma; Cholangitis; Klatskin Tumor
• Other Study ID Numbers: 37℃ Contrast Agent in ERCP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No