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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

November 3, 2010
February 7, 2012
October 2010
December 2010   (final data collection date for primary outcome measure)
Percentage of Liver Fat Content on MRI in Patients With Serious Post-operative Complications (Clavien-Dindo Grade ≥IV) [ Time Frame: December 2010 ] [ Designated as safety issue: Yes ]

Liver fat content, measured by MRI, uses the in-phase/out-of-phase imaging calculated in terms of fat signal fraction (FSF).

The Clavien-Dindo Classification of Surgical Complications:

Grade I: Any deviation from the normal postoperative course without the need for treatment. Grade II: Requiring pharmacological treatment with drugs. Grade III: Requiring surgical, endoscopic or radiological intervention. Grade IV: Life-threatening complication requiring IC/ICU-management. Grade V: Death of a patient

Serious post-operative complications (Clavien-Dindo grade ≥IV) [ Time Frame: December 2010 ] [ Designated as safety issue: Yes ]

The Clavien-Dindo Classification of Surgical Complications:

Grade I: Any deviation from the normal postoperative course without the need for treatment. Grade II: Requiring pharmacological treatment with drugs. Grade III: Requiring surgical, endoscopic or radiological intervention. Grade IV: Life-threatening complication requiring IC/ICU-management. Grade V: Death of a patient

Complete list of historical versions of study NCT01234714 on ClinicalTrials.gov Archive Site
  • Post-operative Alanine Transaminase (ALT) Levels [ Time Frame: December 2010 ] [ Designated as safety issue: No ]
    Alanine Transaminase is commonly measured clinically as a part of a diagnostic evaluation of hepatocellular injury, to determine liver health.
  • Intra-operative Blood Loss [ Time Frame: December 2010 ] [ Designated as safety issue: No ]
    Intra-operative blood loss was defined according to the total volume of blood loss from the beginning until the end of the operation.
  • Operative Time [ Time Frame: December 2010 ] [ Designated as safety issue: No ]
    The operation duration was measured according to the total minutes from the beginning of the operation until the end.
  • Intensive Care Unit (ICU) Stay [ Time Frame: December 2010 ] [ Designated as safety issue: No ]
    The Intensive Care Unit (ICU) stay was calculated according to the total number of days the patients were managed in the ICU. This included also multiple ICU admissions.
  • Hospital Stay [ Time Frame: December 2010 ] [ Designated as safety issue: No ]
    The patient hospital stay was calculated according to the total number of days the patient was hospitalized.
  • Cost [ Time Frame: December 2010 ] [ Designated as safety issue: No ]
    The total in-hospital costs were calculated for each patient in Euros.
  • Type of Post-operative Complications [ Time Frame: December 2010 ] [ Designated as safety issue: Yes ]
    There are several different types of post-operative complications associated with liver surgery, such as liver failure, multi-organ failure, bleeding, bile leak, and sepsis.
  • Post-operative Alanine Transaminase (ALT) levels [ Time Frame: December 2010 ] [ Designated as safety issue: No ]
    Post-operative ALT levels are known markers of liver injury.
  • Intra-operative blood loss [ Time Frame: December 2010 ] [ Designated as safety issue: No ]
    Higher intra-operative blood loss is known to be associated with fatty livers.
  • Operative time [ Time Frame: December 2010 ] [ Designated as safety issue: No ]
    Longer operation time (minutes) may be associated with fatty livers.
  • Intensive Care Unit (ICU) stay [ Time Frame: December 2010 ] [ Designated as safety issue: No ]
    Longer ICU stay (days) is associated with serious complications.
  • Hospital Stay [ Time Frame: December 2010 ] [ Designated as safety issue: No ]
    The length of patient hospitalisation (days) is also associated with complications.
  • Cost [ Time Frame: December 2010 ] [ Designated as safety issue: No ]
    Costs in (US Dollars) are known to increase significantly with complications.
  • Type of post-operative complications [ Time Frame: December 2010 ] [ Designated as safety issue: Yes ]
    There are several different types of post-operative complications associated with liver surgery, such as liver failure, multi-organ failure, bleeding, bile leak, and sepsis.
Not Provided
Not Provided
 
Liver Fat Quantification by Magnetic Resonance Imaging (MRI) - Prediction of Postoperative Complications
Liver Fat Quantification by Magnetic Resonance Imaging (MRI): A Novel Tool for Prediction of Postoperative Complications After Major Liver Resection?

The purpose of this study is to objectively quantify liver fat content (LFC) by Magnetic Resonant Imaging (MRI) prior to major liver surgery, and to investigate its association with post-operative complications.

Lack of agreement exists among expert pathologists in the standard histological assessment of hepatic steatosis on biopsy. The impact of different grades of steatosis on postoperative complications after major liver resection remains controversial.

Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample

Primary care clinics

  • Fatty Liver
  • Surgery
  • Other: Non-invasive Magnetic Resonance Imaging (MRI)
    Conventional pre-operative MRI
    Other Name: Magnetic Resonance Imaging
  • Procedure: Major liver resection
    Hepatectomy of >= 3 liver segments
    Other Name: Hepatectomy = liver resection by open surgery.
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).
Interventions:
  • Other: Non-invasive Magnetic Resonance Imaging (MRI)
  • Procedure: Major liver resection

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
84
July 2011
December 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Major liver resection (>= 3 resected segments).
  • Patients that received a pre-operative Magnetic Resonance Imaging (MRI).
  • Patient over 18 years of age

Exclusion Criteria:

  • Patients that underwent liver surgery but < 3 segments were resected (e.g. wedge liver resection).
  • Patient that did not receive a pre-operative MRI
  • Patient age less than 18 years of age.
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT01234714
MRI_Steatosis_Outcomes
Yes
University of Zurich
University of Zurich
Not Provided
Principal Investigator: Dimitri A Raptis, MD, MSc University Hospital Zurich, Department of Visceral and Transplant Surgery, Zurich, Switzerland
University of Zurich
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP