If Chronic Gallbladder Diseases Increase the Incidence of PEC

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

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)

Study Overview

• Status: Completed
• Conditions: Cholecystitis
• Intervention / Treatment: Procedure: ERCP

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
• Enrollment (Actual): 1019

Contacts and Locations

Study Locations

• China
  • Gansu
    • Longnan, Gansu, China, 746000
      • Chinese herb medicine hospital of Longnan City
    • Tianshui, Gansu, China, 741000
      • The first hospital of Tianshui
    • Wuwei, Gansu, China, 733000
      • Wuwei turmour hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Common bile duct stone ERCP patients with gallbladder in situ

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Chronic gallbladder diseases; Routine ERCP participants with chronic gallbladder diseases	Procedure: ERCP; Routine ERCP procedures with gallbladder in situ patient
Without Chronic gallbladder disease; Routine ERCP participants without chronic gallbladder diseases	Procedure: ERCP; Routine ERCP procedures with gallbladder in situ patient

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hepatopancreatobiliary Surgery Institute of Gansu Province
• Investigators: Principal Investigator: Wenbo Meng, M.D., Ph. D., Hepatopancreatobiliary Surgery Institute of Gansu Province

Publications and helpful links

General Publications

• Cao J, Ding X, Wu H, Shen Y, Zheng R, Peng C, Wang L, Zou X. Classification of the cystic duct patterns and endoscopic transpapillary cannulation of the gallbladder to prevent post-ERCP cholecystitis. BMC Gastroenterol. 2019 Aug 5;19(1):139. doi: 10.1186/s12876-019-1053-6.
• Cao J, Peng C, Ding X, Shen Y, Wu H, Zheng R, Wang L, Zou X. Risk factors for post-ERCP cholecystitis: a single-center retrospective study. BMC Gastroenterol. 2018 Aug 22;18(1):128. doi: 10.1186/s12876-018-0854-3.

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2020
• Primary Completion (Actual): November 16, 2024
• Study Completion (Actual): November 16, 2024

Study Registration Dates

• First Submitted: January 22, 2020
• First Submitted That Met QC Criteria: January 22, 2020
• First Posted (Actual): January 27, 2020

Study Record Updates

• Last Update Posted (Estimated): December 19, 2025
• Last Update Submitted That Met QC Criteria: December 13, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: ERCP; Acute purulent cholecystitis; Bile duct stone; Post-ERCP-Choledocholithiasis PEC
• Additional Relevant MeSH Terms: Digestive System Diseases; Biliary Tract Diseases; Gallbladder Diseases; Cholelithiasis; Cholecystitis; Cholecystolithiasis; Diagnostic Techniques and Procedures; Diagnosis; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Diagnostic Techniques, Surgical; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Endoscopy; Digestive System Surgical Procedures; Diagnostic Imaging; Radiography; Cholangiography; Radiography, Abdominal; Cholangiopancreatography, Endoscopic Retrograde
• Other Study ID Numbers: Chronic gallbladder disease

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No