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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06215040
Other study ID # KNUH2023-09-029-001
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 2, 2024
Est. completion date December 31, 2028

Study information

Verified date January 2024
Source Kyungpook National University Hospital
Contact Jun Heo
Phone 82532005505
Email hero797@hanmail.net
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date December 31, 2028
Est. primary completion date December 31, 2027
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 85 Years
Eligibility 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

Study Design


Intervention

Procedure:
Endoscopic retrograde cholangiopancratography
common bile duct stone removal

Locations

Country Name City State
Korea, Republic of Kyungpook National University Hospital Daegu Gyungsangbok-do

Sponsors (6)

Lead Sponsor Collaborator
Kyungpook National University Hospital Daegu Catholic University Medical Center, Daegu Fatima Hospital, Keimyung University Dongsan Medical Center, Kyungpook National University Chilgok Hospital, Yeungnam University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Score of quality of life Compare the quality of life before and after treatment 3 months
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