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
  Purpose

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.


Condition Intervention
Fatty Liver
Surgery
Other: Non-invasive Magnetic Resonance Imaging (MRI)
Procedure: Major liver resection

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Liver Fat Quantification by Magnetic Resonance Imaging (MRI): A Novel Tool for Prediction of Postoperative Complications After Major Liver Resection?

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • 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



Secondary Outcome Measures:
  • 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.


Enrollment: 84
Study Start Date: October 2010
Study Completion Date: July 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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).
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primary care clinics

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01234714

Locations
Switzerland
University Hospital Zurich, Department of Visceral and Transplant Surgery, Swiss Hepato-Pancreato-Biliary (HPB) Center
Zurich, Switzerland, 8091
University Hospital Zurich, Department of Interventional and Diagnostic Radiology
Zurich, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Dimitri A Raptis, MD, MSc University Hospital Zurich, Department of Visceral and Transplant Surgery, Zurich, Switzerland
  More Information

Additional Information:
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

Keywords provided by University of Zurich:
Fatty Liver
Liver
Magnetic Resonance Imaging
Surgery

Additional relevant MeSH terms:
Fatty Liver
Postoperative Complications
Liver Diseases
Digestive System Diseases
Pathologic Processes
Liver Extracts
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 18, 2014