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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-invasive Magnetic Resonance Imaging (MRI) | Other | Conventional pre-operative MRI |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Primary care clinics
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| Name | Affiliation | Role |
|---|---|---|
| Dimitri A Raptis, MD, MSc | University Hospital Zurich, Department of Visceral and Transplant Surgery, Zurich, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Zurich, Department of Interventional and Diagnostic Radiology | Zurich | Canton of Zurich | 8091 | Switzerland | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19638912 | Background | 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. | |
| 21997548 |
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Patients that underwent liver surgery were recruited at the outpatient clinics.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | According to the Clavien-Dindo Classification of surgical complications: (please see) http://www.surgicalcomplication.info/ | Posted | Median | Inter-Quartile Range | Percentage of liver fat content | December 2010 |
|
Time from MRI to patient hospital discharge after major liver resection.
Serious and/or other [non-serious] adverse events were not collected/assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Dimitri Aristotle Raptis, Principal Investigator | University of Zurich | +41442553300 | dimitri.raptis@usz.ch |
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| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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| Major liver resection | Procedure | Hepatectomy of >= 3 liver segments |
|
|
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 |
| University Hospital Zurich, Department of Visceral and Transplant Surgery, Swiss Hepato-Pancreato-Biliary (HPB) Center |
| Zurich |
| Canton of Zurich |
| 8091 |
| Switzerland |
| 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. |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Percentage of liver fat content on MRI in patients with Clavien-Dindo Grade \
| OG001 | Clavien-Dindo Grade ≥IV Complications | Percentage of liver fat content on MRI in patients with Clavien-Dindo Grade \ |
|
|
| Secondary | 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. | According to the MRI liver fat content measurement. | Posted | Median | Inter-Quartile Range | Units/liter | December 2010 |
|
|
|
| Secondary | 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. | According to MRI | Posted | Median | Inter-Quartile Range | ml | December 2010 |
|
|
|
| Secondary | Operative Time | The operation duration was measured according to the total minutes from the beginning of the operation until the end. | According to MRI | Posted | Median | Inter-Quartile Range | min | December 2010 |
|
|
|
| Secondary | 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. | According to MRI | Posted | Median | Inter-Quartile Range | days | December 2010 |
|
|
|
| Secondary | Hospital Stay | The patient hospital stay was calculated according to the total number of days the patient was hospitalized. | According to MRI | Posted | Median | Inter-Quartile Range | days | December 2010 |
|
|
|
| Secondary | Cost | The total in-hospital costs were calculated for each patient in Euros. | According to MRI | Posted | Mean | Standard Deviation | Euros | December 2010 |
|
|
|
| Secondary | 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. | Not Posted | December 2010 |
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