Pulmonary Embolism After Liver Resection

Pulmonary Embolism After Liver Resection: A Prospective Analysis of Risk Factors

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.

Study Overview

• Status: Unknown
• Conditions: Death; Thrombophilia; Liver Disease; Pulmonary Embolism
• Intervention / Treatment: Procedure: Liver resection; Radiation: Computed Tomography

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

Study Locations

• France
  • Clichy
    • Paris, Clichy, France, 92110
      • Prof. Jacques Belghiti

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• Age >18 years
• Malignant liver diseases
• Benign liver diseases

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Liver resection patients; All patients that underwent elective liver resection for both malignant and benign diseases.	Procedure: Liver resection; Hepatectomy including both minor and major.; Other Names: Hepatectomy, liver resection; Radiation: Computed Tomography; Computed Tomography +/- pulmonary angiography; Other Names: CT, CTPA, CT-PA, MSCT, MSCT-PA

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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.	up to January 2012
Mortality	Post-operative 90-Day Mortality	up to January 2012

Collaborators and Investigators

• Sponsor: Beaujon Hospital
• Investigators: Principal Investigator: Jacques Belghiti, MD, Beaujon Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (Anticipated): January 1, 2012
• Study Completion (Anticipated): January 1, 2012

Study Registration Dates

• First Submitted: December 4, 2011
• First Submitted That Met QC Criteria: December 5, 2011
• First Posted (Estimate): December 6, 2011

Study Record Updates

• Last Update Posted (Estimate): December 6, 2011
• Last Update Submitted That Met QC Criteria: December 5, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Keywords: Pulmonary embolism; Death; Thrombophilia; Liver disease
• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hematologic Diseases; Embolism and Thrombosis; Liver Diseases; Embolism; Pulmonary Embolism; Thrombophilia; Hematinics; Liver Extracts
• Other Study ID Numbers: Beaujon