Clinical trial NCT04242394: If Chronic Gallbladder Diseases Increase the Incidence of PEC
Official title: If Chronic Gallbladder Diseases Increase the Occurence of Post Endoscopic Retrograde Choledochopancreatography Choledocholithiasis（a Prospective Multi-center Cohort Study）
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cholecystitis
Keywords: ERCP
Acute purulent cholecystitis
Bile duct stone
Post-ERCP-Choledocholithiasis PEC
Lead sponsor: Hepatopancreatobiliary Surgery Institute of Gansu Province
Sponsor class: OTHER
First posted: 2020-01-27
Enrollment: 1019
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Common bile duct stone ERCP patients with gallbladder in situ

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Acute PEC(post-ERCP-cholecystitis )
timeFrame: 1month
Secondary outcomes:
measure: Number of Pancreatitis
timeFrame: 1month
measure: Number of Cholangitis
timeFrame: 1 month
measure: Number of Perforation
timeFrame: 1 month
Other outcomes:
Locations:
city: Longnan
country: China
facility: Chinese herb medicine hospital of Longnan City
state: Gansu
city: Tianshui
country: China
facility: The first hospital of Tianshui
state: Gansu
city: Wuwei
country: China
facility: Wuwei turmour hospital
state: Gansu
Study officials:
affiliation: Hepatopancreatobiliary Surgery Institute of Gansu Province
name: Wenbo Meng, M.D., Ph. D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.