Risk Factors for Recurrence of Primary Bile Duct Stones

May 19, 2014 updated by: Jai Hoon Yoon, Chuncheon Sacred Heart Hospital

Case-control Study of Risk Factors for Recurrence of Primary Bile Duct Stones

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gangwon-do
      • Chuncheon, Gangwon-do, Korea, Republic of, 200704
        • Recruiting
        • Chuncheon Sacred Heart Hospital
        • Contact:
        • Principal Investigator:
          • Chang Seok Bang, M.D.
        • Principal Investigator:
          • Jai Hoon Yoon, M.D.,Ph.D
        • Principal Investigator:
          • Hyo Sun Kim, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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 .

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
retrospective (up to 8 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
retrospective (up to 8 years)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
retrospective (up to 8 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chuncheon Sacred Heart Hospital

Investigators

  • Study Chair: Jai Hoon Yoon, M.D..Ph.D., Hallym University College of Medicine, Chuncheon Sacred Heart hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Anticipated)

December 1, 2014

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

May 12, 2014

First Submitted That Met QC Criteria

May 19, 2014

First Posted (Estimate)

May 22, 2014

Study Record Updates

Last Update Posted (Estimate)

May 22, 2014

Last Update Submitted That Met QC Criteria

May 19, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YJH-1
  • ChuncheonSHH YJH-1 (Other Identifier: ChuncheonSHH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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