Clinical trial NCT04234126: The Relationship Between Post-ERCP-choledocholithiasis and Gallbladder Status
Official title: Does the Gallbladder Status Influence the Occurence of Post-Endoscopic Retrograde Choledochopancreatography(ERCP) -Choledocholithiasis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cholecystitis
Keywords: ERCP
Acute purulent cholecystitis
Bile duct stone
PEC(post-ERCP-choledocholithiasis)
Lead sponsor: Hepatopancreatobiliary Surgery Institute of Gansu Province
Sponsor class: OTHER
First posted: 2020-01-21
Enrollment: 1117
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Routine ERCP patients with CBD stones

Brief summary: In this retrospective study, the investigators evaluate the relationship of post-ERCP-choledocholithiasis(PEC ) and the gallbladder status as a risk factor.

Detailed description: When patients have common bile duct(CBD) stones, ERCP is widely used for stone extraction instead of clinical operation. ERCP has many advantages like less injury or faster recovery. However, according to literature, ERCP will has a mostly 10% possibility to get an acute purulent cholecystitis, which often requires emergency intervention, therefore, it is necessary to know if the gallbladder status(chronic disease) is one of the important risk factors of PEC like the gallbladder wall thickness, chronic cholecystitis, polyps,crudely or calculus.

.

Eligibility criteria: Inclusion Criteria:

* Routine ERCP for CBD stone patients with gallbladder in situ

Exclusion Criteria:

* Unwillingness or inability to consent for the study
* Unstable vital signs Coagulation dysfunction (INR\>1.5) and low peripheral blood platelet count (\<50×10 \^9 / L) or using anti-coagulation drugs
* Any Prior surgery for CBD including ERCP
* 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: 1 month
Secondary outcomes:
measure: Number of Participants with Pancreatitis
timeFrame: 1 month
measure: Number of Participants with Cholangitis
timeFrame: 1 month
measure: Number of Participants with Perforation
timeFrame: 1 month
measure: Number of Participants with bile duct stents
timeFrame: 1 month
Other outcomes:
Locations:
city: Lanzhou
country: China
facility: Hepatopancreatobiliary Surgery Institute of Gansu Province
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: Zhang X, Yue P, Zhang J, Yang M, Chen J, Zhang B, Luo W, Wang M, Da Z, Lin Y, Zhou W, Zhang L, Zhu K, Ren Y, Yang L, Li S, Yuan J, Meng W, Leung JW, Li X. A novel machine learning model and a public online prediction platform for prediction of post-ERCP-cholecystitis (PEC). EClinicalMedicine. 2022 May 13;48:101431. doi: 10.1016/j.eclinm.2022.101431. eCollection 2022 Jun.