If Chronic Gallbladder Diseases Increase the Incidence of PEC

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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

October 31, 2022

Primary Completion Date

October 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 2022