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Common Bile Duct Stones - Natural History and Interventions

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ClinicalTrials.gov Identifier: NCT01734720
Recruitment Status : Completed
First Posted : November 28, 2012
Last Update Posted : August 29, 2013
Sponsor:
Collaborator:
Ersta Hospital, Sweden
Information provided by (Responsible Party):
Mats Möller, Karolinska Institutet

Brief Summary:

The aims of this study were to

  1. investigate what measures were taken when common bile duct stones (CBDS) were found intraoperatively in Sweden during the period May 2005 to December 2009 by using data from this population-based nationwide registry, and
  2. analyze the outcome in terms of complications and success rates of bile duct clearance in relation to various stone sizes and interventions used. In order to further characterize the natural course of CBDS of various sizes, particular interest was focused on patients with positive findings where no peroperative measures to clear the bile ducts were taken or planned postoperatively.

Condition or disease
Common Bile Duct Stone

Study Type : Observational
Actual Enrollment : 3828 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Common Bile Duct Stones - Natural History and Interventions : Data From the Swedish Registry for Gallstone Surgery and Endoscopic Retrograde Cholangio Pancreatography (ERCP) (GallRiks)
Study Start Date : May 2005
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Group/Cohort
common bile duct stone
Patients undergoing cholecystectomy



Primary Outcome Measures :
  1. complications in relation to strategy for handling CBDS [ Time Frame: 30 days post operative ]
    Complications reported to the registry at 30 day follow up after surgery


Secondary Outcome Measures :
  1. complications in relation to stone size [ Time Frame: 30 days post operative ]
    Complications reported to the registry at 30 day follow up after surgery



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Ages Eligible for Study:   11 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing cholecystectomy with common bile duct stones found in peroperative cholangiogram
Criteria

Inclusion Criteria:

  • common bile duct stones

Exclusion Criteria:


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): NCT01734720


Sponsors and Collaborators
Karolinska Institutet
Ersta Hospital, Sweden
Investigators
Principal Investigator: Mats Möller, MD Karolinsks Institutet

Responsible Party: Mats Möller, MD. consultant suregon, Ersta Hospital, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01734720     History of Changes
Other Study ID Numbers: 2010/533-31/2
First Posted: November 28, 2012    Key Record Dates
Last Update Posted: August 29, 2013
Last Verified: August 2013

Additional relevant MeSH terms:
Gallstones
Cholelithiasis
Biliary Tract Diseases
Digestive System Diseases
Cholecystolithiasis
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical