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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01234714
First Posted: November 4, 2010
Last Update Posted: February 8, 2012
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.
Information provided by (Responsible Party):
University of Zurich
Results First Submitted: 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
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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 
Overall Participants Analyzed 
[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
  Show All Outcome Measures

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 reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


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


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
First Submitted: November 3, 2010
First Posted: November 4, 2010
Results First Submitted: November 11, 2011
Results First Posted: February 8, 2012
Last Update Posted: February 8, 2012