Common Bile Duct Stones - Natural History and Interventions | NCT01734720

Studies
Common Bile Duct Stones - Natural History and Interventions

NCT01734720

Sponsor

Karolinska Institutet

Status

Completed

Last Update Posted

Aug 29, 2013Estimated

Enrollment

3,828Actual

Phase

Not provided

Conditions

Common Bile Duct Stone

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2005

Primary Completion Date

Dec 2009Actual

Completion Date

Dec 2009Actual

First Submitted Date

Nov 16, 2012

First Submission Date that Met QC Criteria

Nov 21, 2012

First Posted Date

Nov 28, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 28, 2013

Last Update Posted Date

Aug 29, 2013Estimated

Name	Class
Ersta Hospital, Sweden	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aims of this study were to

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
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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

3,828Actual

Label	Type	Description	Intervention Names
common bile duct stone		Patients undergoing cholecystectomy

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

common bile duct stones

Exclusion Criteria:

none

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

11 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mats Möller, MD	Karolinsks Institutet	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D042882	Gallstones

Ancestor Terms

ID	Term
D002769	Cholelithiasis
D001660	Biliary Tract Diseases
D004066	Digestive System Diseases
D041761	Cholecystolithiasis

Browse Leaves

Not provided

Browse Branches

Not provided