Liver DiseaseNCT01486511
Pulmonary Embolism After Liver Resection
An observational study of Liver Disease and Pulmonary Embolism, run by Beaujon Hospital at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Disease, Pulmonary Embolism, Thrombophilia
- What is being tested?
- Liver resection and Computed Tomography
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2007to Jan 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All consecutive patients that will undergo liver resection for any type of liver disease.
Who may be able to join
- Age >18 years
- Malignant liver diseases
- Benign liver diseases
Who cannot join
- Age <18 years
- Previous history of thromboembolic events
- Living Donor hepatectomies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Liver Disease, Pulmonary Embolism, Thrombophilia, Death
- Being tested
- Liver resection, Computed Tomography
- Keywords
- Liver disease, Pulmonary embolism, Thrombophilia, Death
- Medical subject headings
- Liver Diseases, Pulmonary Embolism, Thrombophilia, Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver resectionProcedure or surgery
Also called Hepatectomy, liver resection
Hepatectomy including both minor and major.
Computed TomographyRadiation
Also called CT, CTPA, CT-PA, MSCT, MSCT-PA
Computed Tomography +/- pulmonary angiography
| Study group | Role | What they receive |
|---|---|---|
| Liver resection patients | All patients that underwent elective liver resection for both malignant and benign diseases. Receives: Procedure: Liver resection; Radiation: Computed Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary embolism
Blood clots in the lungs that may lead to sudden death.
Measured: up to January 2012
Secondary outcomes (3)
Complications
Any type of post-operative complications graded according to the Clavien-Dindo Classification of Surgical Complications
Measured: up to January 2012
Length of hospital stay
The duration of hospitalization in days.
Measured: up to January 2012
Mortality
Post-operative 90-Day Mortality
Measured: up to January 2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2011 (estimated)
- Study startJan 2007
- Primary completionJan 2012 (estimated)
- Study completionJan 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beaujon Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emmanuel Melloul, Beaujon Hospital
- Investigators
- Jacques Belghiti, MD, Principal investigator, Beaujon Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01486511
- Sponsor's protocol ID
- Beaujon
- Status last verified
- Dec 2011
- First submitted
- 4 Dec 2011
- Last updated
- 6 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Embolism After Liver Resection: A Prospective Analysis of Risk Factors
- ClinicalTrials.gov ID
- NCT01486511
- Acronym / sponsor ID
- Beaujon
- Conditions
- Liver Disease, Pulmonary Embolism, Thrombophilia, Death
- Keywords
- Liver disease, Pulmonary embolism, Thrombophilia, Death
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Beaujon HospitalUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Jan 2012 (estimated)
- Study completion
- Jan 2012 (estimated)
- First posted
- 6 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liver resection patients | – | Procedure: Liver resection, Radiation: Computed TomographyAll patients that underwent elective liver resection for both malignant and benign diseases. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients that will undergo liver resection for any type of liver disease.
Key inclusion criteria (3 listed)
- Age >18 years
- Malignant liver diseases
- Benign liver diseases
Key exclusion criteria (3 listed)
- Age <18 years
- Previous history of thromboembolic events
- Living Donor hepatectomies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liver resectionAlso: Hepatectomy, liver resectionHepatectomy including both minor and major. | Procedure or surgery | Liver resection patients |
| Computed TomographyAlso: CT, CTPA, CT-PA, MSCT, MSCT-PAComputed Tomography +/- pulmonary angiography | Radiation | Liver resection patients |
Primary outcome
Pulmonary embolism
Time frame: up to January 2012
Blood clots in the lungs that may lead to sudden death.
3 secondary outcomes
Complications
Time frame: up to January 2012
Length of hospital stay
Time frame: up to January 2012
Mortality
Time frame: up to January 2012
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacques Belghiti, MD principal investigator
Beaujon Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Disease and Pulmonary Embolism, run by Beaujon Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary embolism (time frame: up to January 2012). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2011.