The Clinical Characteristics of the Patients With Choledocholithiasis Without Cholangitis
1 other identifier
observational
44
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2012
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 2, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
January 4, 2016
CompletedFirst Posted
Study publicly available on registry
January 6, 2016
CompletedFebruary 3, 2021
February 1, 2021
12 months
January 4, 2016
February 2, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
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)
Eligibility Criteria
"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.
You may qualify if:
- patients were diagnosed with CBD stone under endoscopic retrograde cholangiopancreatography (ERCP)
- 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.
You may not qualify if:
- \. underlying hepatobiliary disease 2. alcoholics 3. cholangitis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 4, 2016
First Posted
January 6, 2016
Study Start
October 2, 2012
Primary Completion
October 1, 2013
Study Completion
October 1, 2013
Last Updated
February 3, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will not share