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NCT Number: NCT04242394

If Chronic Gallbladder Diseases Increase the Incidence of PEC

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)

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Key information

Conditions

Cholecystitis Biliary Tract Diseases Cholecystolithiasis Cholelithiasis Digestive System Diseases Gallbladder Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Chinese herb medicine hospital of Longnan City, Longnan, Gansu, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ERCP

Procedure

Routine ERCP procedures with gallbladder in situ patient

Primary outcomes

  1. Number of Acute PEC(post-ERCP-cholecystitis )

    Time frame: 1month

    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

Secondary outcomes

  1. Number of Pancreatitis

    Time frame: 1month

    Typical abdominal pain, with the level of serum amylase increasing at least 3 times of the normal range within 24 hours after ERCP.

  2. Number of Cholangitis

    Time frame: 1 month

    Temperature should be more than 38 #, right upper abdominal pain, chills or WBC≥10

  3. Number of Perforation

    Time frame: 1 month

    Typical abdominal pain,abdominal muscle tension, tenderness, evidence of free gas in abdominal cavity

Sponsors and collaborators

Lead sponsor

Hepatopancreatobiliary Surgery Institute of Gansu Province

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Jan 27, 2020
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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