If Chronic Gallbladder Diseases Increase the Incidence of PEC

Study Overview
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Brief Summary
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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
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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.

Official Title
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If Chronic Gallbladder Diseases Increase the Occurence of Post Endoscopic Retrograde Choledochopancreatography Choledocholithiasis（a Prospective Multi-center Cohort Study）

Conditions
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Cholecystitis

Intervention / Treatment
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* Procedure: ERCP


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Chronic gallbladder diseases<br>Routine ERCP participants with chronic gallbladder diseases | Procedure: ERCP<br>* Routine ERCP procedures with gallbladder in situ patient<br>|
| Without Chronic gallbladder disease<br>Routine ERCP participants without chronic gallbladder diseases | Procedure: ERCP<br>* Routine ERCP procedures with gallbladder in situ patient<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Acute PEC(post-ERCP-cholecystitis ) | When the PEC occurs, with right upper abdominal pain, White Blood Cell increasing, gallbladder wall ≥4mm or crudely, temperature might be more than 38 degree centigrade | 1month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Pancreatitis | Typical abdominal pain, with the level of serum amylase increasing at least 3 times of the normal range within 24 hours after ERCP. | 1month | 
| Number of Cholangitis | Temperature should be more than 38 #, right upper abdominal pain, chills or WBC≥10 | 1 month | 
| Number of Perforation | Typical abdominal pain,abdominal muscle tension, tenderness, evidence of free gas in abdominal cavity | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ERCP, Acute purulent cholecystitis, Bile duct stone, Post-ERCP-Choledocholithiasis PEC