The Relationship Between Post-ERCP-choledocholithiasis and Gallbladder Status

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Brief Title

The Relationship Between Post-ERCP-choledocholithiasis and Gallbladder Status

Official Title

Does the Gallbladder Status Influence the Occurence of Post-Endoscopic Retrograde Choledochopancreatography(ERCP) -Choledocholithiasis

Brief Summary

      In this retrospective study, the investigators evaluate the relationship of
      post-ERCP-choledocholithiasis(PEC ) and the gallbladder status as a risk factor.

Detailed Description

      When patients have common bile duct(CBD) stones, ERCP is widely used for stone extraction
      instead of clinical operation. ERCP has many advantages like less injury or faster recovery.
      However, according to literature, ERCP will has a mostly 10% possibility to get an acute
      purulent cholecystitis, which often requires emergency intervention, therefore, it is
      necessary to know if the gallbladder status(chronic disease) is one of the important risk
      factors of PEC like the gallbladder wall thickness, chronic cholecystitis, polyps,crudely or
      calculus.

      .

Study Type

Observational

Primary Outcome

Number of Acute PEC(post-ERCP-cholecystitis )

Secondary Outcome

 Number of Participants with Pancreatitis

Condition

Cholecystitis

Intervention

ERCP

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

1117

Start Date

January 31, 2020

Completion Date

November 18, 2021

Primary Completion Date

November 18, 2021

Eligibility Criteria

        Inclusion Criteria:

          -  Routine ERCP for CBD stone patients with gallbladder in situ

        Exclusion Criteria:

          -  Unwillingness or inability to consent for the study

          -  Unstable vital signs Coagulation dysfunction (INR>1.5) and low peripheral blood
             platelet count (<50×10 ^9 / L) or using anti-coagulation drugs

          -  Any Prior surgery for CBD including ERCP

          -  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., ,

Location Countries

China

Location Countries

China

Administrative Informations

NCT ID

NCT04234126

Organization ID

Gallbladder status and PEC

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

November 2021