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Common Bile Duct Stones - Natural History and Interventions

This study has been completed.
Sponsor:
Collaborator:
Ersta Hospital, Sweden
Information provided by (Responsible Party):
Mats Möller, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01734720
First received: November 16, 2012
Last updated: November 21, 2012
Last verified: November 2012
History of Changes
  Purpose

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
Common Bile Duct Stone

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:

MedlinePlus related topics: Gallstones
U.S. FDA Resources

Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • complications in relation to strategy for handling CBDS [ Time Frame: 30 days post operative ] [ Designated as safety issue: No ]
    Complications reported to the registry at 30 day follow up after surgery


Secondary Outcome Measures:
  • complications in relation to stone size [ Time Frame: 30 days post operative ] [ Designated as safety issue: No ]
    Complications reported to the registry at 30 day follow up after surgery


Enrollment: 3828
Study Start Date: May 2005
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
common bile duct stone
Patients undergoing cholecystectomy

  Eligibility

Ages Eligible for Study:   11 Years and older
Genders Eligible for Study:   Both
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:

  • none
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01734720

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

No publications provided

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
Study First Received: November 16, 2012
Last Updated: November 21, 2012
Health Authority: Sweden: The National Board of Health and Welfare

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

ClinicalTrials.gov processed this record on May 22, 2013