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

Overview

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.

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

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: December 2010

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.

Interventions

  • Other: Non-invasive Magnetic Resonance Imaging (MRI)
    • Conventional pre-operative MRI
  • Procedure: Major liver resection
    • Hepatectomy of >= 3 liver segments

Arms, Groups and Cohorts

  • 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).

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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.
  • 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.
  • 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.
  • 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.
  • Hospital Stay
    • Time Frame: December 2010
    • The patient hospital stay was calculated according to the total number of days the patient was hospitalized.
  • Cost
    • Time Frame: December 2010
    • The total in-hospital costs were calculated for each patient in Euros.
  • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Zurich
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Dimitri A Raptis, MD, MSc, Principal Investigator, University Hospital Zurich, Department of Visceral and Transplant Surgery, Zurich, Switzerland

References

Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2.

Citations Reporting on Results

Raptis DA, Fischer MA, Graf R, Nanz D, Weber A, Moritz W, Tian Y, Oberkofler CE, Clavien PA. MRI: the new reference standard in quantifying hepatic steatosis? Gut. 2012 Jan;61(1):117-27. doi: 10.1136/gutjnl-2011-300155. Epub 2011 Oct 13.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.