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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Surgery, Fatty Liver

Intervention / Treatment
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* Other: Non-invasive Magnetic Resonance Imaging (MRI)
* Procedure: Major liver resection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Major liver resection<br>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)<br>* Conventional pre-operative MRI<br>* Other names: Magnetic Resonance Imaging;Procedure: Major liver resection<br>* Hepatectomy of >= 3 liver segments<br>* Other names: Hepatectomy = liver resection by open surgery.;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fatty Liver, Liver, Magnetic Resonance Imaging, Surgery