If Chronic Gallbladder Diseases Increase the Incidence of PEC

Completed

• Conditions: Cholecystitis
• Interventions: Procedure: ERCP

• Registration Number: NCT04242394
• Lead Sponsor: Hepatopancreatobiliary Surgery Institute of Gansu Province

Brief Summary

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

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 Timeline

• Study First Submitted: 2020-01-22
• Study First Submitted QC: 2020-01-22
• Study First Posted: 2020-01-27
• Study Start: 2020-02-14
• Status Verified: 2024-11
• Primary Completion: 2024-11-16
• Study Completion: 2024-11-16
• Last Update Submitted: 2024-11-16
• Last Update Posted: 2024-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1019

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Chronic gallbladder diseases	ERCP	Routine ERCP participants with chronic gallbladder diseases
Without Chronic gallbladder disease	ERCP	Routine ERCP participants without chronic gallbladder diseases

Primary Outcome Measures

Name	Time	Method
Number of Acute PEC(post-ERCP-cholecystitis )	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 Outcome Measures

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

Trial Locations

Locations (3)

Chinese herb medicine hospital of Longnan City; 🇨🇳 Longnan, Gansu, China

The first hospital of Tianshui; 🇨🇳 Tianshui, Gansu, China

Wuwei turmour hospital; 🇨🇳 Wuwei, Gansu, China