Pulmonary Embolism After Liver Resection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01486511
Recruitment Status : Unknown
Verified December 2011 by Emmanuel Melloul, Beaujon Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : December 6, 2011
Last Update Posted : December 6, 2011
Information provided by (Responsible Party):
Emmanuel Melloul, Beaujon Hospital

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.

Condition or disease Intervention/treatment
Liver Disease Pulmonary Embolism Thrombophilia Death Procedure: Liver resection Radiation: Computed Tomography

Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pulmonary Embolism After Liver Resection: A Prospective Analysis of Risk Factors
Study Start Date : January 2007
Estimated Primary Completion Date : January 2012
Estimated Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: Hepatectomy, liver resection
Radiation: Computed Tomography
Computed Tomography +/- pulmonary angiography

Primary Outcome Measures :
  1. Pulmonary embolism [ Time Frame: up to January 2012 ]
    Blood clots in the lungs that may lead to sudden death.

Secondary Outcome Measures :
  1. Complications [ Time Frame: up to January 2012 ]
    Any type of post-operative complications graded according to the Clavien-Dindo Classification of Surgical Complications

  2. Length of hospital stay [ Time Frame: up to January 2012 ]
    The duration of hospitalization in days.

  3. Mortality [ Time Frame: up to January 2012 ]
    Post-operative 90-Day Mortality

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All consecutive patients that will undergo liver resection for any type of liver disease.

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01486511

Prof. Jacques Belghiti
Paris, Clichy, France, 92110
Sponsors and Collaborators
Beaujon Hospital
Principal Investigator: Jacques Belghiti, MD Beaujon Hospital

Responsible Party: Emmanuel Melloul, Medical Doctor, Surgeon, Beaujon Hospital Identifier: NCT01486511     History of Changes
Other Study ID Numbers: Beaujon
First Posted: December 6, 2011    Key Record Dates
Last Update Posted: December 6, 2011
Last Verified: December 2011

Keywords provided by Emmanuel Melloul, Beaujon Hospital:
Liver disease
Pulmonary embolism

Additional relevant MeSH terms:
Liver Diseases
Pulmonary Embolism
Digestive System Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Hematologic Diseases
Liver Extracts