Liver Fat Quantification by Magnetic Resonance Imaging (MRI) - Prediction of Postoperative Complications (MRsteatosis)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01234714
First received: November 3, 2010
Last updated: February 7, 2012
Last verified: February 2012
Results First Received: November 11, 2011  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Retrospective
Conditions: Fatty Liver
Surgery
Interventions: Other: Non-invasive Magnetic Resonance Imaging (MRI)
Procedure: Major liver resection

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients that underwent liver surgery were recruited at the outpatient clinics.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Major Liver Resection This single Cohort/Group will include all consecutive patients that received pre-operative Magnetic Resonant Imaging (MRI) and underwent major liver resection (>=3 segments).

Participant Flow:   Overall Study
    Major Liver Resection  
STARTED     84  
COMPLETED     84  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Major Liver Resection This single Cohort/Group will include all consecutive patients that received pre-operative Magnetic Resonant Imaging (MRI) and underwent major liver resection (>=3 segments).

Baseline Measures
    Major Liver Resection  
Number of Participants  
[units: participants]
  84  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     67  
>=65 years     17  
Age  
[units: years]
Mean ± Standard Deviation
  54  ± 15  
Gender  
[units: participants]
 
Female     40  
Male     44  
Region of Enrollment  
[units: participants]
 
Switzerland     84  



  Outcome Measures
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1.  Primary:   Percentage of Liver Fat Content on MRI in Patients With Serious Post-operative Complications (Clavien-Dindo Grade ≥IV)   [ Time Frame: December 2010 ]

2.  Secondary:   Post-operative Alanine Transaminase (ALT) Levels   [ Time Frame: December 2010 ]

3.  Secondary:   Intra-operative Blood Loss   [ Time Frame: December 2010 ]

4.  Secondary:   Operative Time   [ Time Frame: December 2010 ]

5.  Secondary:   Intensive Care Unit (ICU) Stay   [ Time Frame: December 2010 ]

6.  Secondary:   Hospital Stay   [ Time Frame: December 2010 ]

7.  Secondary:   Cost   [ Time Frame: December 2010 ]

8.  Secondary:   Type of Post-operative Complications   [ Time Frame: December 2010 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Dr Dimitri Aristotle Raptis, Principal Investigator
Organization: University of Zurich
phone: +41442553300
e-mail: dimitri.raptis@usz.ch


Publications of Results:
Other Publications:

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01234714     History of Changes
Other Study ID Numbers: MRI_Steatosis_Outcomes
Study First Received: November 3, 2010
Results First Received: November 11, 2011
Last Updated: February 7, 2012
Health Authority: Switzerland: Swissmedic