The Clinical Characteristics of the Patients With Choledocholithiasis Without Cholangitis

The Clinical Characteristics of the Patients With Choledocholithiasis Without Cholangitis Showing the High Level of Aminotransferase and the Establishment of New Nomenclature ; Gallstone Hepatitis

Laboratory change induced by common bile duct (CBD) stone is in general observed as the higher elevation of alkaline phosphatase (ALP) and gamma-glutamyl transpeptideas (ɤ-GT), in comparison to those of aspartate aminotransferase (AST) and alanine aminotransferase (ALT). However, some patients with CBD stone show the marked increased level of aminotransferase, which sometimes leads to misdiagnose those as liver disease caused by viral hepatitis, ischemia, and drug toxicity. The aim of this study is to investigate the clinicopathologic features of patients with CBD stones with the high level of aminotransferase in serum.

Study Overview

• Status: Completed
• Conditions: Choledocholithiasis

• Study Type: Observational
• Enrollment (Actual): 44

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

"Patients have been diagnosed as CBD stone under endoscopic retrograde cholangiopancreatography (ERCP). Among patients, patients who displayed above 400 IU/L of aminotransferase without cholangitis (gallstone hepatitis group) and patients who showed the normal value of aminotransferase (control group) were enrolled in this study. We estimated two groups by comparing clinical features, lab finding, radiologic images, and findings under ERCP such as CBD diameter, CBD stone diameter, CBD stone number, periampullary diverticulum.

Description

Inclusion Criteria:

1. patients were diagnosed with CBD stone under endoscopic retrograde cholangiopancreatography (ERCP)
2. patients showing above 400 IU/L of aminotransferase when at the first admitted into hospital and the control groups is the patients displaying normal AST and ALT.

Exclusion Criteria:

• 1. underlying hepatobiliary disease 2. alcoholics 3. cholangitis

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
gallstone hepatitis group,; gallstone hepatitis group (Among patients diagnosed as CBD stone who displayed above 400 IU/L of aminotransferase without cholangitis),
control group; control group (Among patients diagnosed as CBD stone who showed the normal value of aminotransferase)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinicopathologic features of patients with CBD stones with the high level of aminotransferase	lab finding, radiologic images, and findings under ERCP such as CBD diameter, CBD stone diameter, CBD stone number, periampullary diverticulum.	1year

Collaborators and Investigators

• Sponsor: Gangnam Severance Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2012
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: January 4, 2016
• First Submitted That Met QC Criteria: January 4, 2016
• First Posted (Estimate): January 6, 2016

Study Record Updates

• Last Update Posted (Actual): February 3, 2021
• Last Update Submitted That Met QC Criteria: February 2, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Biliary Tract Diseases; Bile Duct Diseases; Common Bile Duct Diseases; Cholelithiasis; Cholangitis; Choledocholithiasis
• Other Study ID Numbers: 3-2012-0165

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No