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If Chronic Gallbladder Diseases Increase the Incidence of PEC

NCT ID: NCT04242394

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1019 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-14

Study Completion Date

2024-11-16

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.

Conditions

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Cholecystitis

Keywords

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ERCP Acute purulent cholecystitis Bile duct stone Post-ERCP-Choledocholithiasis PEC

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Chronic gallbladder diseases

Routine ERCP participants with chronic gallbladder diseases

ERCP

Intervention Type PROCEDURE

Routine ERCP procedures with gallbladder in situ patient

Without Chronic gallbladder disease

Routine ERCP participants without chronic gallbladder diseases

ERCP

Intervention Type PROCEDURE

Routine ERCP procedures with gallbladder in situ patient

Interventions

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ERCP

Routine ERCP procedures with gallbladder in situ patient

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hepatopancreatobiliary Surgery Institute of Gansu Province

OTHER

Sponsor Role lead

Responsible Party

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Wenbo Meng

M.D., Ph. D, Direct of surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wenbo Meng, M.D., Ph. D.

Role: PRINCIPAL_INVESTIGATOR

Hepatopancreatobiliary Surgery Institute of Gansu Province

Locations

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Chinese herb medicine hospital of Longnan City

Longnan, Gansu, China

Site Status

The first hospital of Tianshui

Tianshui, Gansu, China

Site Status

Wuwei turmour hospital

Wuwei, Gansu, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 31382888 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30134864 (View on PubMed)

Other Identifiers

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Chronic gallbladder disease

Identifier Type: -

Identifier Source: org_study_id