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Completed

NCT Number: NCT01234714

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

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.

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Key information

Conditions

Fatty Liver Digestive System Diseases Liver Diseases Surgery

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Zurich, Department of Interventional and Diagnostic Radiology, Zurich, Canton of Zurich, Switzerland

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Non-invasive Magnetic Resonance Imaging (MRI)

Other

Conventional pre-operative MRI

Other names: Magnetic Resonance Imaging

Major liver resection

Procedure

Hepatectomy of >= 3 liver segments

Other names: Hepatectomy = liver resection by open surgery.

Primary outcomes

  1. Percentage of Liver Fat Content on MRI in Patients With Serious Post-operative Complications (Clavien-Dindo Grade ≥IV)

    Time frame: December 2010

    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 outcomes

  1. Post-operative Alanine Transaminase (ALT) Levels

    Time frame: December 2010

    Alanine Transaminase is commonly measured clinically as a part of a diagnostic evaluation of hepatocellular injury, to determine liver health.

  2. Intra-operative Blood Loss

    Time frame: December 2010

    Intra-operative blood loss was defined according to the total volume of blood loss from the beginning until the end of the operation.

  3. Operative Time

    Time frame: December 2010

    The operation duration was measured according to the total minutes from the beginning of the operation until the end.

  4. Intensive Care Unit (ICU) Stay

    Time frame: December 2010

    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.

  5. Hospital Stay

    Time frame: December 2010

    The patient hospital stay was calculated according to the total number of days the patient was hospitalized.

  6. Cost

    Time frame: December 2010

    The total in-hospital costs were calculated for each patient in Euros.

  7. Type of Post-operative Complications

    Time frame: December 2010

    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.

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

Liver Fat Quantification by Magnetic Resonance Imaging (MRI): A Novel Tool for Prediction of Postoperative Complications After Major Liver Resection?

Acronym: MRsteatosis

Important dates

Study start
2010
Primary completion
2010
Study completion
2011
First posted
Nov 4, 2010
Registry last updated
Feb 8, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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