Liver Fat Quantification by Magnetic Resonance Imaging (MRI) - Prediction of Postoperative Complications (MRsteatosis)
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|