Brief Title
If Chronic Gallbladder Diseases Increase the Incidence of PEC
Official Title
If Chronic Gallbladder Diseases Increase the Occurence of Post Endoscopic Retrograde Choledochopancreatography Choledocholithiasis(a Prospective Multi-center Cohort Study)
Brief Summary
This is a prospective, multi-centre trial conducts at 4 ERCP centers in China designed to determine if chronic gallbladder diseases increase the incidence of Post-Endoscopic Retrograde Choledochopancreatography-Choledocholithiasis (PEC)
Detailed Description
Endoscopic Retrograde Choledochopancreatography(ERCP) has the advantages of less injury and faster recovery for common bile duct stone patients. However, according to our retrospective study, ERCP will has a mostly 10% possibility to get an acute purulent cholecystitis which often requires emergency intervention, when patients combined with chronic gallbladder diseases, such as chronic cholecystitis, asymptomatic gallstones, and gallbladder wall thickness, the incidence of PEC will increase accordingly. The aim of this study is to observe if chronic gallbladder disease will increase the occurence of PEC and develop a high-risk PEC model.
Study Type
Observational
Primary Outcome
Number of Acute PEC(post-ERCP-cholecystitis )
Secondary Outcome
Number of Pancreatitis
Condition
Cholecystitis
Intervention
ERCP
Study Arms / Comparison Groups
Chronic gallbladder diseases
Description: Routine ERCP participants with chronic gallbladder diseases
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
152
Start Date
February 14, 2020
Completion Date
January 31, 2022
Primary Completion Date
January 31, 2022
Eligibility Criteria
Inclusion Criteria: - ERCP patients with gallbladder in situ Exclusion Criteria: - Acute cholecystitis before surgery - Gallbladder has been removed - Gastrointestinal reconstruction - Unwillingness or inability to consent for the study - Unstable vital signs Coagulation dysfunction (INR>1.5) - Low peripheral blood platelet count (<50×10 ^9 / L) or using anti-coagulation drugs - Preoperative coexistent diseases: acute pancreatitis, GI tract hemorrhage, severe liver disease (such as decompensated liver cirrhosis, liver failure and so on), septic shock Biliary- duodenal fistula confirmed during ERCP - Pregnant women or breastfeeding
Gender
All
Ages
18 Years - 90 Years
Accepts Healthy Volunteers
No
Contacts
Wenbo Meng, M.D., Ph. D., +8613919177177, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT04242394
Organization ID
Chronic gallbladder disease
Responsible Party
Principal Investigator
Study Sponsor
Hepatopancreatobiliary Surgery Institute of Gansu Province
Study Sponsor
Wenbo Meng, M.D., Ph. D., Principal Investigator, Hepatopancreatobiliary Surgery Institute of Gansu Province
Verification Date
March 2020