Pulmonary Embolism After Liver Resection
This study is enrolling participants by invitation only.
Sponsor:
Beaujon Hospital
Information provided by (Responsible Party):
Emmanuel Melloul, Beaujon Hospital
ClinicalTrials.gov Identifier:
NCT01486511
First received: December 4, 2011
Last updated: December 5, 2011
Last verified: December 2011
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Purpose
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 | Intervention |
|---|---|
|
Liver Disease Pulmonary Embolism Thrombophilia Death |
Procedure: Liver resection Radiation: Computed Tomography |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Pulmonary Embolism After Liver Resection: A Prospective Analysis of Risk Factors |
Resource links provided by NLM:
Further study details as provided by Beaujon Hospital:
Primary Outcome Measures:
- Pulmonary embolism [ Time Frame: up to January 2012 ] [ Designated as safety issue: Yes ]Blood clots in the lungs that may lead to sudden death.
Secondary Outcome Measures:
- Complications [ Time Frame: up to January 2012 ] [ Designated as safety issue: Yes ]Any type of post-operative complications graded according to the Clavien-Dindo Classification of Surgical Complications
- Length of hospital stay [ Time Frame: up to January 2012 ] [ Designated as safety issue: No ]The duration of hospitalization in days.
- Mortality [ Time Frame: up to January 2012 ] [ Designated as safety issue: Yes ]Post-operative 90-Day Mortality
| Estimated Enrollment: | 500 |
| Study Start Date: | January 2007 |
| Estimated Study Completion Date: | January 2012 |
| Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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
Other Name: CT, CTPA, CT-PA, MSCT, MSCT-PA
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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.
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Emmanuel Melloul, Medical Doctor, Surgeon, Beaujon Hospital |
| ClinicalTrials.gov Identifier: | NCT01486511 History of Changes |
| Other Study ID Numbers: | Beaujon |
| Study First Received: | December 4, 2011 |
| Last Updated: | December 5, 2011 |
| Health Authority: | France: Institutional Ethical Committee |
Keywords provided by Beaujon Hospital:
|
Liver disease Pulmonary embolism Thrombophilia Death |
Additional relevant MeSH terms:
|
Death Embolism Liver Diseases Pulmonary Embolism Thrombophilia Pathologic Processes Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases |
Digestive System Diseases Lung Diseases Respiratory Tract Diseases Hematologic Diseases Liver Extracts Hematinics Hematologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013