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NCT02647593 Clinical Trial

The Clinical Characteristics of the Patients With Choledocholithiasis Without Cholangitis

Choledocholithiasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02647593
Other study ID # 3-2012-0165
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 2, 2012
Est. completion date October 1, 2013

Study information
Verified date February 2021
Source Gangnam Severance Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 44
Est. completion date October 1, 2013
Est. primary completion date October 1, 2013
Accepts healthy volunteers No
Gender All
Age group 20 Years to 90 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Gangnam Severance Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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