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The Treatment Effect for Asymptomatic Common Bile Duct Stone

Multicenter Prospective Study for Efficacy of Asymptomatic Common Bile Duct Stone Treatment

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06215040
Enrollment
120
Registered
2024-01-22
Start date
2024-01-02
Completion date
2028-12-31
Last updated
2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asymptomatic Condition, Choledocholithiasis, Quality of Life

Brief summary

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

Detailed 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.

Interventions

PROCEDUREEndoscopic retrograde cholangiopancratography

common bile duct stone removal

Sponsors

Yeungnam University Hospital
CollaboratorOTHER
Keimyung University Dongsan Medical Center
CollaboratorOTHER
Daegu Catholic University Medical Center
CollaboratorOTHER
Kyungpook National University Chilgok Hospital
CollaboratorOTHER
Daegu Fatima Hospital
CollaboratorOTHER
Kyungpook National University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Score of quality of life3 monthsCompare the quality of life before and after treatment

Countries

South Korea

Contacts

Primary ContactJun Heo
hero797@hanmail.net82532005505

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026