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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
Sponsor:
Information provided by (Responsible Party):
Tae Hoon Lee, Soon Chun Hyang University

Study Description
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Brief 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. 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.

Condition or disease
Common Bile Duct Stones Gallbladder in Situ Choleretics Biliary Complications

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gallstones

Groups and Cohorts
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Group/Cohort
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


Outcome Measures
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Primary Outcome Measures :
  1. Complications [ Time Frame: two year ]
    The primary outcome is biliary complications between two groups during follow-up.


Secondary Outcome Measures :
  1. Natural outcomes [ Time Frame: two year ]
    Other outcome measures included adverse events after choleretics and natural clinical courses of gallbladder in situ.

  2. Other adverse events [ Time Frame: two year ]
    Other outcome measures included adverse events after choleretics and natural outcomes of gallbladder in situ.


Other Outcome Measures:
  1. Drug-related adverse event [ Time Frame: three months ]
    Other outcome measure includes adverse events after choleretics.


Eligibility Criteria
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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
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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Tae Hoon Lee, MD, PhD +82-41-570-3662 thlee9@schmc.ac.kr

Locations
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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         
Sponsors and Collaborators
Soon Chun Hyang University
More Information
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Additional Information:

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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
Keywords provided by Tae Hoon Lee, Soon Chun Hyang University:
Common bile duct stone
Gallbladder in situ
Choleretics
Additional relevant MeSH terms:
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Cholelithiasis
Cholecystolithiasis
Gallstones
Calculi
 Pathological Conditions, Anatomical
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases