CholedocholithiasisNCT02647593
The Clinical Characteristics of the Patients With Choledocholithiasis Without Cholangitis
An observational study of Choledocholithiasis, run by Gangnam Severance Hospital.
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). Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Choledocholithiasis
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- 2 Oct 2012to 1 Oct 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 1. underlying hepatobiliary disease 2. alcoholics 3. cholangitis
About this study
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
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.
- Conditions
- Choledocholithiasis
- Medical subject headings
- Choledocholithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2016 (estimated)
- Study start2 Oct 2012
- Primary completion1 Oct 2013
- Study completion1 Oct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholedocholithiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong Ki Lee, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02647593
- Sponsor's protocol ID
- 3-2012-0165
- Status last verified
- Feb 2021
- First submitted
- 4 Jan 2016
- Last updated
- 3 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02647593
- Acronym / sponsor ID
- 3-2012-0165
- Conditions
- Choledocholithiasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- 2 Oct 2012 (actual)
- Primary completion
- 1 Oct 2013 (actual)
- Study completion
- 1 Oct 2013 (actual)
- First posted
- 6 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 1. underlying hepatobiliary disease 2. alcoholics 3. cholangitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Choledocholithiasis, run by Gangnam Severance Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinicopathologic features of patients with CBD stones with the high level of aminotransferase (time frame: 1year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2021.