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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

Tracking Information
First Submitted Date April 4, 2013
First Posted Date April 11, 2013
Last Update Posted Date April 11, 2013
Study Start Date March 2012
Estimated Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 8, 2013)
Complications [ Time Frame: two year ]
The primary outcome is biliary complications between two groups during follow-up.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: April 8, 2013)
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 8, 2013)
Drug-related adverse event [ Time Frame: three months ]
Other outcome measure includes adverse events after choleretics.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Efficacy of Choleretics in Acalculous Gallbladder in Situ After Endoscopic Removal of Biliary Stones
Official Title A Prospective Multicenter Comparative Study for Efficacy of Choleretics in Acalculous Gallbladder in Situ After Endoscopic Removal of Biliary Stones
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.
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration 2 Years
Biospecimen Not Provided
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.
Condition
  • Common Bile Duct Stones
  • Gallbladder in Situ
  • Choleretics
  • Biliary Complications
Intervention Not Provided
Study Groups/Cohorts
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 8, 2013)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2021
Estimated Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Tae Hoon Lee, MD, PhD +82-41-570-3662 thlee9@schmc.ac.kr
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT01829139
Other Study ID Numbers SCH-MULTI
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Tae Hoon Lee, Soon Chun Hyang University
Study Sponsor Soon Chun Hyang University
Collaborators Not Provided
Investigators Not Provided
PRS Account Soon Chun Hyang University
Verification Date April 2013