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Common Bile Duct Stone Management: What Have we Learned? (CBDS)

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ClinicalTrials.gov Identifier: NCT02155244
Recruitment Status : Completed
First Posted : June 4, 2014
Last Update Posted : June 4, 2014
Sponsor:
Information provided by (Responsible Party):
Luca Regusci, Ospedale Regionale di Mendrisio

Brief Summary:
In unfit elderly people with comorbid disease leaving the gallbladder in situ is justified after ERCP treatment. Cholangitis is more present in elderly people. The purpose of this study is to determine leaving the gallbladder in situ does not reduce the morbidity rate after ERCP for common bile duct stones(CBDS), especially in patients with cholangitis.

Condition or disease
Common Bile Duct Stones

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Study Type : Observational
Actual Enrollment : 101 participants
Observational Model: Cohort
Time Perspective: Retrospective
Study Start Date : January 2006
Actual Primary Completion Date : January 2014
Actual Study Completion Date : May 2014

Group/Cohort
Common bile duct stones
Common bile duct stones traeted with ERCP
CBDS
treated with ERCP combined with surgery



Primary Outcome Measures :
  1. Post-operative complications according to Clavien-Dindo classification [ Time Frame: During patients hospitalization (median hospital stay was 9 days) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 94 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary care clinic
Criteria

Inclusion Criteria:

- Patients with common bile duct stones (CBDS)

Exclusion Criteria:

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Responsible Party: Luca Regusci, MD, Ospedale Regionale di Mendrisio
ClinicalTrials.gov Identifier: NCT02155244    
Other Study ID Numbers: LR-1234
First Posted: June 4, 2014    Key Record Dates
Last Update Posted: June 4, 2014
Last Verified: June 2014
Keywords provided by Luca Regusci, Ospedale Regionale di Mendrisio:
CBDS
ERCP
Dindo-Clavien classification