Liver Fat Quantification by Magnetic Resonance Imaging (MRI) - Prediction of Postoperative Complications
- Conditions
- Fatty LiverSurgery
- Interventions
- Other: Non-invasive Magnetic Resonance Imaging (MRI)Procedure: Major liver resection
- Registration Number
- NCT01234714
- Lead Sponsor
- University of Zurich
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 84
- Major liver resection (>= 3 resected segments).
- Patients that received a pre-operative Magnetic Resonance Imaging (MRI).
- Patient over 18 years of age
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Major liver resection Non-invasive Magnetic Resonance Imaging (MRI) This single Cohort/Group will include all consecutive patients that received pre-operative Magnetic Resonant Imaging (MRI) and underwent major liver resection (\>=3 segments). Major liver resection 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).
- Primary Outcome Measures
Name Time Method Percentage of Liver Fat Content on MRI in Patients With Serious Post-operative Complications (Clavien-Dindo Grade ≥IV) 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 Outcome Measures
Name Time Method Post-operative Alanine Transaminase (ALT) Levels 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 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 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 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 December 2010 The patient hospital stay was calculated according to the total number of days the patient was hospitalized.
Cost December 2010 The total in-hospital costs were calculated for each patient in Euros.
Type of Post-operative Complications 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.
Trial Locations
- Locations (2)
University Hospital Zurich, Department of Interventional and Diagnostic Radiology
🇨🇭Zurich, Switzerland
University Hospital Zurich, Department of Visceral and Transplant Surgery, Swiss Hepato-Pancreato-Biliary (HPB) Center
🇨🇭Zurich, Switzerland