Common Bile Duct Stones - Natural History and Interventions

Common Bile Duct Stone Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01734720
• Other study ID #: 2010/533-31/2
• Status: Completed
• Phase: N/A
• First received: November 16, 2012
• Last updated: August 28, 2013
• Start date: May 2005
• Est. completion date: December 2009

Study information

• Verified date: August 2013
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: The National Board of Health and Welfare
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3828
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 11 Years and older

Eligibility

Inclusion Criteria:

• common bile duct stones

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Common Bile Duct Stone
• Gallstones

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Ersta Hospital, Sweden

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	complications in relation to strategy for handling CBDS	Complications reported to the registry at 30 day follow up after surgery	30 days post operative	No
Secondary	complications in relation to stone size	Complications reported to the registry at 30 day follow up after surgery	30 days post operative	No