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CompletedNCT02647593Updated Feb 3, 2021

The Clinical Characteristics of the Patients With Choledocholithiasis Without Cholangitis

An observational study in Choledocholithiasis, sponsored by Gangnam Severance Hospital. Completed. Open to participants aged 20 Years to 90 Years. Per ClinicalTrials.gov, last updated 2021-02-03.

Sponsored by Gangnam Severance Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
44
Ages
20 Years to 90 Years
Sex
All
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Study 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.

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Conditions studied

  • Choledocholithiasis
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In context

Cholangitis

228 studies on the registry are indexed under Cholangitis; 32 are open to participants now.

This study's enrollment of 44 is below the median of 140 across 65 observational studies indexed under Cholangitis.

Browse Cholangitis studies →

Lead sponsor

Gangnam Severance Hospital is the lead sponsor of 141 studies on the registry; 37 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 90 Years
Sexes eligible
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.

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

Exclusion Criteria:

    1. underlying hepatobiliary disease 2. alcoholics 3. cholangitis
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
44 participants (actual)
Patient registry
No

Groups and cohorts

  • 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)

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What researchers measure

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.

    Time frame: 1year

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 3, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02647593
Lead sponsor
Gangnam Severance Hospital
Responsible party
Dong Ki Lee (Professor, Gangnam Severance Hospital) — Principal investigator
First posted
Jan 6, 2016
Start date
Oct 2, 2012
Primary completion
Oct 1, 2013
Completion
Oct 1, 2013
Last update
Feb 3, 2021

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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