Pulmonary Embolism After Liver Resection | NCT01486511

Studies
Pulmonary Embolism After Liver Resection

NCT01486511

Sponsor

Beaujon Hospital

Status

Unknown status

Last Update Posted

Dec 6, 2011Estimated

Enrollment

500Estimated

Phase

Not provided

Conditions

Liver Disease
Pulmonary Embolism
Thrombophilia
Death

Interventions

Liver resection
Computed Tomography

Countries

France

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2007

Primary Completion Date

Jan 2012Estimated

Completion Date

Jan 2012Estimated

First Submitted Date

Dec 4, 2011

First Submission Date that Met QC Criteria

Dec 5, 2011

First Posted Date

Dec 6, 2011Estimated

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

Dec 5, 2011

Last Update Posted Date

Dec 6, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Major surgery is associated with a postoperative hypercoagulable state related to the surgical trauma that may lead to thromboembolic complications. To the investigators knowledge, only two series have reported the risk of PE after liver surgery with an incidence of up to 6.3% The purpose of this study is to identify the independent risk factors associated with the development of PE after elective liver surgery.

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

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Liver resection patients		All patients that underwent elective liver resection for both malignant and benign diseases.	Procedure: Liver resection Radiation: Computed Tomography

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Liver resection	Procedure	Hepatectomy including both minor and major.	Liver resection patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pulmonary embolism	Blood clots in the lungs that may lead to sudden death.	up to January 2012

Secondary Outcomes

Measure	Description	Time Frame
Complications	Any type of post-operative complications graded according to the Clavien-Dindo Classification of Surgical Complications	up to January 2012
Length of hospital stay	The duration of hospitalization in days.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age >18 years
Malignant liver diseases
Benign liver diseases

Exclusion Criteria:

Age <18 years
Previous history of thromboembolic events
Living Donor hepatectomies

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All consecutive patients that will undergo liver resection for any type of liver disease.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jacques Belghiti, MD	Beaujon Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Prof. Jacques Belghiti		Paris	Clichy	92110	France

Type	Date	Date Unknown
Release	Jan 12, 2016
Reset	Feb 8, 2016

Submission Tracking

Estimated Results First Submitted Date

Jan 12, 2016

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jan 12, 2016			Feb 8, 2016

Condition Browse Module

MeSH Terms

ID	Term
D008107	Liver Diseases
D011655	Pulmonary Embolism
D019851	Thrombophilia
D003643	Death

Ancestor Terms

ID	Term
D004066	Digestive System Diseases
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D004617	Embolism

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D006498	Hepatectomy
C074011	4-((1,4,8,11-tetraazacyclotetradec-1-yl)methyl)benzoic acid

Ancestor Terms

ID	Term
D013505	Digestive System Surgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided