Liver Fat Quantification by Magnetic Resonance Imaging (MRI) - Prediction of Postoperative Complications (MRsteatosis)
|ClinicalTrials.gov Identifier: NCT01234714|
Recruitment Status : Completed
First Posted : November 4, 2010
Results First Posted : February 8, 2012
Last Update Posted : February 8, 2012
|Condition or disease||Intervention/treatment|
|Fatty Liver Surgery||Other: Non-invasive Magnetic Resonance Imaging (MRI) Procedure: Major liver resection|
|Study Type :||Observational|
|Actual Enrollment :||84 participants|
|Official Title:||Liver Fat Quantification by Magnetic Resonance Imaging (MRI): A Novel Tool for Prediction of Postoperative Complications After Major Liver Resection?|
|Study Start Date :||October 2010|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||July 2011|
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 Name: Magnetic Resonance ImagingProcedure: Major liver resection
Hepatectomy of >= 3 liver segments
Other Name: Hepatectomy = liver resection by open surgery.
- 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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01234714
|University Hospital Zurich, Department of Interventional and Diagnostic Radiology|
|Zurich, Switzerland, 8091|
|University Hospital Zurich, Department of Visceral and Transplant Surgery, Swiss Hepato-Pancreato-Biliary (HPB) Center|
|Zurich, Switzerland, 8091|
|Principal Investigator:||Dimitri A Raptis, MD, MSc||University Hospital Zurich, Department of Visceral and Transplant Surgery, Zurich, Switzerland|