Common Bile Duct Stones - Natural History and Interventions

Common Bile Duct Stones - Natural History and Interventions : Data From the Swedish Registry for Gallstone Surgery and Endoscopic Retrograde Cholangio Pancreatography (ERCP) (GallRiks)

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.

Study Overview

• Status: Completed
• Conditions: Common Bile Duct Stone

• Study Type: Observational
• Enrollment (Actual): 3828

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing cholecystectomy with common bile duct stones found in peroperative cholangiogram

Description

Inclusion Criteria:

• common bile duct stones

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
common bile duct stone; Patients undergoing cholecystectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
complications in relation to strategy for handling CBDS	Complications reported to the registry at 30 day follow up after surgery	30 days post operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
complications in relation to stone size	Complications reported to the registry at 30 day follow up after surgery	30 days post operative

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Ersta Hospital, Sweden
• Investigators: Principal Investigator: Mats Möller, MD, Karolinsks Institutet

Study record dates

Study Major Dates

• Study Start: May 1, 2005
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: November 16, 2012
• First Submitted That Met QC Criteria: November 21, 2012
• First Posted (Estimate): November 28, 2012

Study Record Updates

• Last Update Posted (Estimate): August 29, 2013
• Last Update Submitted That Met QC Criteria: August 28, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathological Conditions, Anatomical; Gallbladder Diseases; Biliary Tract Diseases; Cholelithiasis; Cholecystolithiasis; Calculi; Gallstones
• Other Study ID Numbers: 2010/533-31/2