Common Bile Duct StonesNCT01829139
Efficacy of Choleretics in Acalculous Gallbladder in Situ After Endoscopic Removal of Biliary Stones
An observational study of Common Bile Duct Stones and Gallbladder in Situ, run by Soon Chun Hyang University at 1 site in South Korea.
Trial summary
In patients with gallbladder in situ after complete removal of common bile duct (CBD) stones, there is no definite guideline for the management of remnant acalculous gallbladder. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Common Bile Duct Stones, Gallbladder in Situ, Choleretics
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2012to Dec 2021
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We randomized patients (>18 years of age) who underwent therapeutic endoscopic biliary sphincterotomy and/or balloon dilation for the complete clearance of their bile duct stones.
Who may be able to join
- Complete clearance of CBD stones
- No definite GB stones
- Agree with the study protocol
Who cannot join
- < 18 years of age
- Concomitant IHD stones
- Combined malignancy with a limted life span
- Prior cholecystectomy state
- refusal to agree to the study protocol
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Soon Chun Hyang University Cheonan Hospital
Cheonan, Chungcheongnam-do, 330-721
Tae Hoon Lee, MD, PhD
Tae Hoon Lee, MD, PhD
About this study
Official title: A Prospective Multicenter Comparative Study for Efficacy of Choleretics in Acalculous Gallbladder in Situ After Endoscopic Removal of Biliary Stones
In patients with gallbladder in situ after complete removal of common bile duct (CBD) stones, there is no definite guideline for the management of remnant acalculous gallbladder. This study was planned to evaluate the efficacy of choleretic agents in those patients comparing with non-treatment group during short (2 years) and long-term (5 to 10 years) period. So that, the investigators want to establish the treatment guideline in gallbladder in situ without definite stones following complete removal of CBD stones. Second, the protective or preventive effect of choleretics may be defined.
- Keywords
- Common bile duct stone, Gallbladder in situ, Choleretics
- Medical subject headings
- Gallstones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Wait-and-see group | After endoscopic clearance of their bile duct stones, this group of patients will be follow up without additional managements | |
| Choleretics group | After endoscopic clearance of their bile duct stones, this group of patients receives choleretic agents during 3 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications
The primary outcome is biliary complications between two groups during follow-up.
Measured: two year
Secondary outcomes (2)
Natural outcomes
Other outcome measures included adverse events after choleretics and natural clinical courses of gallbladder in situ.
Measured: two year
Other adverse events
Other outcome measures included adverse events after choleretics and natural outcomes of gallbladder in situ.
Measured: two year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2013 (estimated)
- Study startMar 2012
- Primary completionFeb 2014 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Common Bile Duct StonesStudies 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
- 200 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Soon Chun Hyang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tae Hoon Lee, Soon Chun Hyang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01829139
- Sponsor's protocol ID
- SCH-MULTI
- Status last verified
- Apr 2013
- First submitted
- 4 Apr 2013
- Last updated
- 11 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter Comparative Study for Efficacy of Choleretics in Acalculous Gallbladder in Situ After Endoscopic Removal of Biliary Stones
- ClinicalTrials.gov ID
- NCT01829139
- Acronym / sponsor ID
- SCH-MULTI
- Keywords
- Common bile duct stone, Gallbladder in situ, Choleretics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Soon Chun Hyang UniversityUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Feb 2014 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 11 Apr 2013 (estimated)
- 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.
In patients with gallbladder in situ after complete removal of common bile duct (CBD) stones, there is no definite guideline for the management of remnant acalculous gallbladder. This study was planned to evaluate the efficacy of choleretic agents in those patients comparing with non-treatment group during short (2 years) and long-term (5 to 10 years) period. So that, the investigators want to establish the treatment guideline in gallbladder in situ without definite stones following complete removal of CBD stones. Second, the protective or preventive effect of choleretics may be defined.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wait-and-see group | – | –After endoscopic clearance of their bile duct stones, this group of patients will be follow up without additional managements |
| Choleretics group | – | –After endoscopic clearance of their bile duct stones, this group of patients receives choleretic agents during 3 months |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We randomized patients (>18 years of age) who underwent therapeutic endoscopic biliary sphincterotomy and/or balloon dilation for the complete clearance of their bile duct stones.
Key inclusion criteria (3 listed)
- Complete clearance of CBD stones
- No definite GB stones
- Agree with the study protocol
Key exclusion criteria (5 listed)
- < 18 years of age
- Concomitant IHD stones
- Combined malignancy with a limted life span
- Prior cholecystectomy state
- refusal to agree to the study protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Complications
Time frame: two year
The primary outcome is biliary complications between two groups during follow-up.
2 secondary outcomes
Natural outcomes
Time frame: two year
Other adverse events
Time frame: two year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2013.
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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. This study is not recruiting at the moment.
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 Common Bile Duct Stones and Gallbladder in Situ, run by Soon Chun Hyang University 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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 11 Apr 2013. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tae Hoon Lee, MD, PhD (+82-41-570-3662, thlee9@schmc.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complications (time frame: two year). 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 11 Apr 2013.