The Treatment Effect for Asymptomatic Common Bile Duct Stone

NCT ID: NCT06215040

Last Updated: 2024-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-02

Study Completion Date

2028-12-31

Brief Summary

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This study is prospective, multicenter study for identify the characteristics of asymptomatic common bile duct stones and effectiveness of treatment.

Detailed Description

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There is no conflcts for treatment of symptomatic common bile duct stone. As more imaging examination such as healthy screening, more asymptomatic common bile duct stone patients are found. Current guideline for aymptomatic common bile duct stone is removal using endoscopic retrograde cholangiopancreatography. However, the previous studies that support this guideline included patients who just underwent cholecystectomy and were diagnosed as common bile duct stone. There is no prospective study for identify the treatment effectiveness of common bile duct stone removal in asymptomatic patients who are dignosed in healthy screening. Therefore, we are going to find the effectiveness of common bile duct stone removal by comparing questionnarie before and after removal of common bile duct stone in asymptomatic and incidentally found common bile duct stone patients. In addition, we are going to follow up patients who do not want to undergo common bile duct stone removal and find the rate of cholangitis risk. We also want to identify extact complication rate for endoscopic retrograde pancreatocholangiographic procedures in asymptomatic common bile duct stone.

Conditions

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Choledocholithiasis Asymptomatic Condition Quality of Life

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Asymptomatic common bile duct stone

Endoscopic retrograde cholangiopancratography

Intervention Type PROCEDURE

common bile duct stone removal

Interventions

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Endoscopic retrograde cholangiopancratography

common bile duct stone removal

Intervention Type PROCEDURE

Other Intervention Names

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observation

Eligibility Criteria

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Inclusion Criteria

* diagnosed as common bile duct stone by image modality examination
* agreement for this study enrollment

Exclusion Criteria

* no definite common bile duct stone by image modality examination
* symptomatic patients who complain with fever/abdominal pain that compatible with common bile duct stone related symptom
* previously diagnosed as pancreatobiliary malignancy
* previously treated by endoscopic or percutaneous treatment for bile duct stones
* severe cardio or pulmonary disease
* pregnancy or possibility of pregnancy
* who do not agree with study enrollment
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Yeungnam University Hospital

OTHER

Sponsor Role collaborator

Keimyung University Dongsan Medical Center

OTHER

Sponsor Role collaborator

Daegu Catholic University Medical Center

OTHER

Sponsor Role collaborator

Kyungpook National University Chilgok Hospital

OTHER

Sponsor Role collaborator

Daegu Fatima Hospital

OTHER

Sponsor Role collaborator

Kyungpook National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jun Heo

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kyungpook National University Hospital

Daegu, Gyungsangbok-do, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Jun Heo

Role: CONTACT

82532005505

Facility Contacts

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Jun Heo

Role: primary

Other Identifiers

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KNUH2023-09-029-001

Identifier Type: -

Identifier Source: org_study_id

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