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Risk Factors for Recurrence of Primary Bile Duct Stones

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ClinicalTrials.gov Identifier: NCT02144493
Recruitment Status : Unknown
Verified May 2014 by Jai Hoon Yoon, Chuncheon Sacred Heart Hospital.
Recruitment status was:  Recruiting
First Posted : May 22, 2014
Last Update Posted : May 22, 2014
Sponsor:
Information provided by (Responsible Party):
Jai Hoon Yoon, Chuncheon Sacred Heart Hospital

Brief Summary:
Recurrent common bile duct stone is one of the risk factors of recurrent cholangitis. However, the exact pathophysiology or mechanism of recurrent cholangitis has not been established. Periampullary diverticulum and narrow angle of common bile duct have been postulated as risk factors of recurrent common bile duct stone. The aim of this study was to evaluate the association between periampullary dierticulum, angle of common bile duct and recurrent common bile duct stone.

Condition or disease Intervention/treatment
Common Bile Duct Stones Other: The existence of periampullary diverticulum Other: CBD angle

Detailed Description:

Recurrent common bile duct stone is one of the risk factors of recurrent cholangitis. However, the exact pathophysiology or mechanism of recurrent cholangitis has not been established. Periampullary diverticulum and narrow angle of common bile duct have been postulated as risk factors of recurrent common bile duct stone. The aim of this study was to evaluate the association between periampullary dierticulum, angle of common bile duct and recurrent common bile duct stone.

This study is patient-control setting study. Firstly, from July 2007 through February 2014, all the patients who were performed ERCP will be enrolled. The inclusion criteria is the patients with common bile duct stone. The exclusion criteria is patients with biliary stenosis, PSC, retained GB stone, or who were lost to follow-up. The main outcome is the association between periampullary diverticulum, common bile duct angle, and recurrent CBD stone. This will be evaluated by univariate and multivariate analyses.


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Study Type : Observational
Estimated Enrollment : 2 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Case-control Study of Risk Factors for Recurrence of Primary Bile Duct Stones
Study Start Date : May 2014
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patients with recurrent CBD stone Other: The existence of periampullary diverticulum
Periampullary diverticulum has been postulated as risk factor of recurrent CBD stone.

Other: CBD angle
Narrow CBD angle has been postulated as risk factor for the development of recurrent CBD stone

Patients without recurrent CBD stone Other: The existence of periampullary diverticulum
Periampullary diverticulum has been postulated as risk factor of recurrent CBD stone.

Other: CBD angle
Narrow CBD angle has been postulated as risk factor for the development of recurrent CBD stone




Primary Outcome Measures :
  1. The association between existence of periampullary diverticulum and recurrent CBD stone [ Time Frame: retrospective (up to 8 years) ]
    The association between existence of periampullary diverticulum and recurrent CBD stone will be assessed by univariate analysis.(unit of analysis: odds ratio, statistical method: Fisher's exact test)


Secondary Outcome Measures :
  1. The association between common bile duct angle and existence of recurrent CBD stone [ Time Frame: retrospective (up to 8 years) ]
    The association between common bile duct angle and recurrent CBD stone will be assessed by univariate analysis (unit of analysis: angle, statistical method: student's t test)


Other Outcome Measures:
  1. The risk factors for the development of recurrent CBD stone [ Time Frame: retrospective (up to 8 years) ]
    The risk factors for the development of recurrent CBD stone will be assessed by multivariate analysis, based on results of univariate analyses. (statistical method: logistic regression analysis)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who were diagnosed as CBD stone or calculous cholangitis will be enrolled. These patients will be divided by patienst with recurrent CBD stone (devlopment of CBD stone after 1 year from the first development of CBD stone) or not .
Criteria

Inclusion Criteria:

  • Patients who were performed ERCP due to CBD stone or calculous cholangitis

Exclusion Criteria:

  • Patients with biliary stricture, PSC, retained GB stone, or who were lost to follow-up.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02144493


Contacts
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Contact: Jai Hoon Yoon, M.D.,Ph.D. +821032553957 jaihoonyoon@gmail.com

Locations
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Korea, Republic of
Chuncheon Sacred Heart Hospital Recruiting
Chuncheon, Gangwon-do, Korea, Republic of, 200704
Contact: Young Hee Lee    82332405128    hcslib128@hallym.or.kr   
Principal Investigator: Chang Seok Bang, M.D.         
Principal Investigator: Jai Hoon Yoon, M.D.,Ph.D         
Principal Investigator: Hyo Sun Kim, M.D.         
Sponsors and Collaborators
Chuncheon Sacred Heart Hospital
Investigators
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Study Chair: Jai Hoon Yoon, M.D..Ph.D. Hallym University College of Medicine, Chuncheon Sacred Heart hospital

Publications:
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Responsible Party: Jai Hoon Yoon, Professor Jai Hoon Yoon, Chuncheon Sacred Heart Hospital
ClinicalTrials.gov Identifier: NCT02144493     History of Changes
Other Study ID Numbers: YJH-1
ChuncheonSHH YJH-1 ( Other Identifier: ChuncheonSHH )
First Posted: May 22, 2014    Key Record Dates
Last Update Posted: May 22, 2014
Last Verified: May 2014

Keywords provided by Jai Hoon Yoon, Chuncheon Sacred Heart Hospital:
common bile duct stones
diverticulum

Additional relevant MeSH terms:
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Recurrence
Calculi
Disease Attributes
Pathologic Processes
Pathological Conditions, Anatomical