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

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ClinicalTrials.gov Identifier: NCT03104569
Recruitment Status : Recruiting
First Posted : April 7, 2017
Last Update Posted : June 5, 2018
Sponsor:
Information provided by (Responsible Party):
Xun Li, Hepatopancreatobiliary Surgery Institute of Gansu Province

Brief 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.

Condition or disease Intervention/treatment Phase
Cholangitis Procedure: Injection of 37℃ contrast agent Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of 37℃ Non-ionic Contrast Agent During ERCP Procedure in Hilar Cholangiocarcinoma: A Prospective Double-blind Multicenter Randomized Controlled Study
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : April 1, 2019
Estimated Study Completion Date : April 1, 2019

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Number of participants with Acute cholangitis [ Time Frame: 2 weeks ]
    Acute cholangitis is defined if patients experienced abdominal pain, high fever(over 38.5℃), or chill after procedure in 2 weeks


Secondary Outcome Measures :
  1. The ease of injection [ Time Frame: During procedures ]
    The ease of contrast agent injection has been considered by ERCP assistant, a questionnaire is required to assign by the assistant

  2. Number of Participants With Abnormal Laboratory Values [ Time Frame: 4 days ]
    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

  3. Operation time [ Time Frame: intraoperative ]
    Total time of procedure

  4. X-ray exposure time [ Time Frame: intraoperative ]
    The total time of X-ray exposure

  5. Number of participants with Post-ERCP pancreatitis [ Time Frame: 1 months ]
    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.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03104569


Contacts
Contact: Wenbo Meng, M.D., Ph. D. +8613919177177 mengwb@lzu.edu.cn
Contact: Xun Li, M.D., Ph. D. +8613993138612 drlixun@163.com

Locations
China, Gansu
The first hospital of Lanzhou university Recruiting
Lanzhou, Gansu, China, 730000
Contact: Wence Zhou, M. D.    +8609318356919    zhouwc129@163.com   
Contact: Wenbo Meng, M. D.    +8609318356213    mengwb@lzu.edu.cn   
China, Shaanxi
The first affiliated hospital of Xi 'an jiaotong university Not yet recruiting
Xi'an, Shaanxi, China, 710061
Contact: Hao Sun, M. D.    +86 13891813691    sunhaoxjfy@126.com   
China, Tianjin
Tianjin Nankai Hospital Not yet recruiting
Tianjin, Tianjin, China, 300100
Contact: Zhenyu Wang, M. D.    +86 15302021661    Wangzytj@163.com   
Sponsors and Collaborators
Hepatopancreatobiliary Surgery Institute of Gansu Province
Investigators
Study Chair: Xun Li, M.D., Ph. D. Hepatopancreatobiliary Surgery Institute of Gansu Province

Responsible Party: Xun Li, M.D., Ph. D, Director., Hepatopancreatobiliary Surgery Institute of Gansu Province
ClinicalTrials.gov Identifier: NCT03104569     History of Changes
Other Study ID Numbers: 37℃ Contrast Agent in ERCP
First Posted: April 7, 2017    Key Record Dates
Last Update Posted: June 5, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Xun Li, Hepatopancreatobiliary Surgery Institute of Gansu Province:
ERCP
Contrast agent
Hilar cholangiocarcinoma
Cholangitis
Nonionic

Additional relevant MeSH terms:
Cholangiocarcinoma
Cholangitis
Klatskin Tumor
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases