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The Clinical Characteristics of the Patients With Choledocholithiasis Without Cholangitis

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ClinicalTrials.gov Identifier: NCT02647593
Recruitment Status : Unknown
Verified January 2016 by Dong Ki Lee, Gangnam Severance Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : January 6, 2016
Last Update Posted : January 6, 2016
Sponsor:
Information provided by (Responsible Party):
Dong Ki Lee, Gangnam Severance Hospital

Brief 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.

Condition or disease
Choledocholithiasis

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Study Start Date : June 2006
Actual Primary Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hepatitis

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)



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



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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

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Responsible Party: Dong Ki Lee, Professor, Gangnam Severance Hospital
ClinicalTrials.gov Identifier: NCT02647593     History of Changes
Other Study ID Numbers: 3-2012-0165
First Posted: January 6, 2016    Key Record Dates
Last Update Posted: January 6, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Cholangitis
Choledocholithiasis
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Common Bile Duct Diseases
Cholelithiasis