Clinical trial NCT06215040: The Treatment Effect for Asymptomatic Common Bile Duct Stone
Official title: Multicenter Prospective Study for Efficacy of Asymptomatic Common Bile Duct Stone Treatment
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Choledocholithiasis
Asymptomatic Condition
Quality of Life
Lead sponsor: Kyungpook National University Hospital
Sponsor class: OTHER
Collaborators: name: Yeungnam University Hospital
name: Keimyung University Dongsan Medical Center
name: Daegu Catholic University Medical Center
name: Kyungpook National University Chilgok Hospital
name: Daegu Fatima Hospital
First posted: 2024-01-22
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy volunteers who have common bile duct stones without cholangitis symptom

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.

Eligibility criteria: 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

Primary outcomes:
measure: Score of quality of life
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
state: Gyungsangbok-do
Study officials:
References: