CholedocholithiasisNCT06215040
The Treatment Effect for Asymptomatic Common Bile Duct Stone
An observational study of Choledocholithiasis and Asymptomatic Condition, run by Kyungpook National University Hospital at 1 site in South Korea.
Trial summary
This study is prospective, multicenter study for identify the characteristics of asymptomatic common bile duct stones and effectiveness of treatment. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Choledocholithiasis, Asymptomatic Condition, Quality of Life
- What is being tested?
- Endoscopic retrograde cholangiopancratography
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Jan 2024to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers who have common bile duct stones without cholangitis symptom
Who may be able to join
- diagnosed as common bile duct stone by image modality examination
- agreement for this study enrollment
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Kyungpook National University Hospital
Daegu, Gyungsangbok-do
Jun Heo, hero797@hanmail.net
About this study
Official title: Multicenter Prospective Study for Efficacy of Asymptomatic Common Bile Duct Stone Treatment
This study is prospective, multicenter study for identify the characteristics of asymptomatic common bile duct stones and effectiveness of treatment.
Read the 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.
- Conditions
- Choledocholithiasis, Asymptomatic Condition, Quality of Life
- Being tested
- Endoscopic retrograde cholangiopancratography
- Medical subject headings
- Choledocholithiasis, Asymptomatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic retrograde cholangiopancratographyProcedure or surgery
Also called observation
common bile duct stone removal
| Study group | Role | What they receive |
|---|---|---|
| Asymptomatic common bile duct stone | Not described Receives: Procedure: Endoscopic retrograde cholangiopancratography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score of quality of life
Compare the quality of life before and after treatment
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start2 Jan 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholedocholithiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kyungpook National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Yeungnam University Hospital, Keimyung University Dongsan Medical Center, Daegu Catholic University Medical Center, Kyungpook National University Chilgok Hospital, Daegu Fatima Hospital
- Responsible party
- Principal investigator, Jun Heo, Kyungpook National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06215040
- Sponsor's protocol ID
- KNUH2023-09-029-001
- Status last verified
- Jan 2024
- First submitted
- 10 Jan 2024
- Last updated
- 22 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Prospective Study for Efficacy of Asymptomatic Common Bile Duct Stone Treatment
- ClinicalTrials.gov ID
- NCT06215040
- Acronym / sponsor ID
- KNUH2023-09-029-001
- Conditions
- Choledocholithiasis, Asymptomatic Condition, Quality of Life
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Kyungpook National University HospitalUniversity, hospital or other
- Collaborators
- Yeungnam University Hospital, Keimyung University Dongsan Medical Center, Daegu Catholic University Medical Center, Kyungpook National University Chilgok Hospital, Daegu Fatima Hospital
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 22 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Asymptomatic common bile duct stone | – | Procedure: Endoscopic retrograde cholangiopancratography |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers who have common bile duct stones without cholangitis symptom
Key inclusion criteria (2 listed)
- diagnosed as common bile duct stone by image modality examination
- agreement for this study enrollment
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic retrograde cholangiopancratographyAlso: observationcommon bile duct stone removal | Procedure or surgery | Asymptomatic common bile duct stone |
Primary outcome
Score of quality of life
Time frame: 3 months
Compare the quality of life before and after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Choledocholithiasis and Asymptomatic Condition, run by Kyungpook National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jun Heo (82532005505, hero797@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score of quality of life (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2024.