The Relationship Between Post-ERCP-choledocholithiasis and Gallbladder Status

Does the Gallbladder Status Influence the Occurence of Post-Endoscopic Retrograde Choledochopancreatography(ERCP) -Choledocholithiasis

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

Study Overview

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

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.

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• Study Type: Observational
• Enrollment (Actual): 1117

Contacts and Locations

Study Locations

• China
  • Gansu
    • Lanzhou, Gansu, China, 730000
      • Hepatopancreatobiliary Surgery Institute of Gansu Province

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Probability Sample

Study Population

Routine ERCP patients with CBD stones

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

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, the temperature should be more than 38 celsius degree, right upper abdominal pain, the total amount of the White Blood Cell (WBC) is above normal for the patients who with the gallbladder wall thickness under ultrasound examination.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Pancreatitis	Typical abdominal pain, with the level of serum amylase increasing at least 3 times of the normal range within 24 hours after ERCP.	1 month
Number of Participants with Cholangitis	Temperature should be more than 38 celsius degree, chills, with right upper abdominal pain, blood routine showing the total amount of the White Blood Cell (WBC), and the amount of polymorphonuclear neutrophil(PMN) are above normal	1 month
Number of Participants with Perforation	Typical abdominal pain,abdominal muscle tension, and there are also radiographic evidence suggesting	1 month
Number of Participants with bile duct stents	If it is necessary to get the patients drainage, Number of Participants with stents or endoscopic nasobiliary drainage (ENBD) should be recorded	1 month

Collaborators and Investigators

• Sponsor: 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2020
• Primary Completion (Actual): November 18, 2021
• Study Completion (Actual): November 18, 2021

Study Registration Dates

• First Submitted: January 13, 2020
• First Submitted That Met QC Criteria: January 17, 2020
• First Posted (Actual): January 21, 2020

Study Record Updates

• Last Update Posted (Actual): November 19, 2021
• Last Update Submitted That Met QC Criteria: November 18, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: ERCP; Acute purulent cholecystitis; Bile duct stone; PEC(post-ERCP-choledocholithiasis)
• Additional Relevant MeSH Terms: Digestive System Diseases; Gallbladder Diseases; Biliary Tract Diseases; Bile Duct Diseases; Common Bile Duct Diseases; Cholelithiasis; Cholecystitis; Acalculous Cholecystitis; Choledocholithiasis
• Other Study ID Numbers: Gallbladder status and PEC

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