Efficacy of Choleretics in Acalculous Gallbladder in Situ After Endoscopic Removal of Biliary Stones
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ClinicalTrials.gov Identifier: NCT01829139 |
Recruitment Status :
Recruiting
First Posted : April 11, 2013
Last Update Posted : April 11, 2013
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Condition or disease |
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Common Bile Duct Stones Gallbladder in Situ Choleretics Biliary Complications |
Study Type : | Observational [Patient Registry] |
Estimated Enrollment : | 200 participants |
Observational Model: | Case-Control |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 2 Years |
Official Title: | A Prospective Multicenter Comparative Study for Efficacy of Choleretics in Acalculous Gallbladder in Situ After Endoscopic Removal of Biliary Stones |
Study Start Date : | March 2012 |
Estimated Primary Completion Date : | February 2014 |
Estimated Study Completion Date : | December 2021 |
Group/Cohort |
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Wait-and-see group
After endoscopic clearance of their bile duct stones, this group of patients will be follow up without additional managements
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Choleretics group
After endoscopic clearance of their bile duct stones, this group of patients receives choleretic agents during 3 months
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- Complications [ Time Frame: two year ]The primary outcome is biliary complications between two groups during follow-up.
- Natural outcomes [ Time Frame: two year ]Other outcome measures included adverse events after choleretics and natural clinical courses of gallbladder in situ.
- Other adverse events [ Time Frame: two year ]Other outcome measures included adverse events after choleretics and natural outcomes of gallbladder in situ.
- Drug-related adverse event [ Time Frame: three months ]Other outcome measure includes adverse events after choleretics.

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Ages Eligible for Study: | 18 Years to 90 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- Complete clearance of CBD stones
- No definite GB stones
- Agree with the study protocol
Exclusion Criteria:
- < 18 years of age
- Concomitant IHD stones
- Combined malignancy with a limted life span
- Prior cholecystectomy state
- refusal to agree to the study protocol

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01829139
Contact: Tae Hoon Lee, MD, PhD | +82-41-570-3662 | thlee9@schmc.ac.kr |
Korea, Republic of | |
Soon Chun Hyang University Cheonan Hospital | Recruiting |
Cheonan, Chungcheongnam-do, Korea, Republic of, 330-721 | |
Contact: Tae Hoon Lee, MD, PhD | |
Principal Investigator: Tae Hoon Lee, MD, PhD |
Responsible Party: | Tae Hoon Lee, Principal Investigator, Soon Chun Hyang University |
ClinicalTrials.gov Identifier: | NCT01829139 |
Other Study ID Numbers: |
SCH-MULTI |
First Posted: | April 11, 2013 Key Record Dates |
Last Update Posted: | April 11, 2013 |
Last Verified: | April 2013 |
Common bile duct stone Gallbladder in situ Choleretics |
Cholelithiasis Cholecystolithiasis Gallstones Calculi |
Pathological Conditions, Anatomical Biliary Tract Diseases Digestive System Diseases Gallbladder Diseases |