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If Chronic Gallbladder Diseases Increase the Incidence of PEC

H

Hepatopancreatobiliary Surgery Institute of Gansu Province

Status

Completed

Conditions

Cholecystitis

Treatments

Procedure: ERCP

Study type

Observational

Funder types

Other

Identifiers

NCT04242394
Chronic gallbladder disease

Details and patient eligibility

About

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)

Full 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.

Enrollment

1,019 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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

Trial design

1,019 participants in 2 patient groups

Chronic gallbladder diseases
Description:
Routine ERCP participants with chronic gallbladder diseases
Treatment:
Procedure: ERCP
Without Chronic gallbladder disease
Description:
Routine ERCP participants without chronic gallbladder diseases
Treatment:
Procedure: ERCP

Trial contacts and locations

3

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Central trial contact

Wenbo Meng, M.D., Ph. D.; Ping Yue, M.D., Ph. D.

Data sourced from clinicaltrials.gov

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