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

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.

Study Overview

• Status: Completed
• Conditions: Fatty Liver; Surgery
• Intervention / Treatment: Other: Non-invasive Magnetic Resonance Imaging (MRI); Procedure: Major liver resection

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.

• Study Type: Observational
• Enrollment (Actual): 84

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, 8091
    • 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Primary care clinics

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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 Names: Magnetic Resonance Imaging; Procedure: Major liver resection; Hepatectomy of >= 3 liver segments; Other Names: Hepatectomy = liver resection by open surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Liver Fat Content on MRI in Patients With Serious Post-operative Complications (Clavien-Dindo Grade ≥IV)	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	December 2010

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative Alanine Transaminase (ALT) Levels	Alanine Transaminase is commonly measured clinically as a part of a diagnostic evaluation of hepatocellular injury, to determine liver health.	December 2010
Intra-operative Blood Loss	Intra-operative blood loss was defined according to the total volume of blood loss from the beginning until the end of the operation.	December 2010
Operative Time	The operation duration was measured according to the total minutes from the beginning of the operation until the end.	December 2010
Intensive Care Unit (ICU) Stay	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.	December 2010
Hospital Stay	The patient hospital stay was calculated according to the total number of days the patient was hospitalized.	December 2010
Cost	The total in-hospital costs were calculated for each patient in Euros.	December 2010
Type of Post-operative Complications	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.	December 2010

Collaborators and Investigators

• Sponsor: University of Zurich
• Investigators: Principal Investigator: Dimitri A Raptis, MD, MSc, University Hospital Zurich, Department of Visceral and Transplant Surgery, Zurich, Switzerland

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: November 3, 2010
• First Submitted That Met QC Criteria: November 3, 2010
• First Posted (Estimate): November 4, 2010

Study Record Updates

• Last Update Posted (Estimate): February 8, 2012
• Last Update Submitted That Met QC Criteria: February 7, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: Surgery; Magnetic Resonance Imaging; Liver; Fatty Liver
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fatty Liver; Postoperative Complications; Hematinics; Liver Extracts
• Other Study ID Numbers: MRI_Steatosis_Outcomes