Fatty Liver, Surgery
Conditions
Keywords
Fatty Liver, Liver, Magnetic Resonance Imaging, Surgery
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.
Interventions
Conventional pre-operative MRI
PROCEDUREMajor liver resection
Hepatectomy of \>= 3 liver segments
Sponsors
University of Zurich
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| Hospital Stay | December 2010 | The patient hospital stay was calculated according to the total number of days the patient was hospitalized. |
Countries
Switzerland
Participant flow
Recruitment details
Patients that underwent liver surgery were recruited at the outpatient clinics.
Participants by arm
| Arm | Count |
|---|---|
| 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). | 84 |
| Total | 84 |
Baseline characteristics
| Characteristic | Major Liver Resection |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 17 Participants |
| Age, Categorical Between 18 and 65 years | 67 Participants |
| Age Continuous | 54 years STANDARD_DEVIATION 15 |
| Region of Enrollment Switzerland | 84 participants |
| Sex: Female, Male Female | 40 Participants |
| Sex: Female, Male Male | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
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
Time frame: December 2010
Population: According to the Clavien-Dindo Classification of surgical complications: (please see) http://www.surgicalcomplication.info/
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Clavien-Dindo Grade <IV Complications | Percentage of Liver Fat Content on MRI in Patients With Serious Post-operative Complications (Clavien-Dindo Grade ≥IV) | 1.3 Percentage of liver fat content |
| Clavien-Dindo Grade ≥IV Complications | Percentage of Liver Fat Content on MRI in Patients With Serious Post-operative Complications (Clavien-Dindo Grade ≥IV) | 13.6 Percentage of liver fat content |
Secondary
Cost
The total in-hospital costs were calculated for each patient in Euros.
Time frame: December 2010
Population: According to MRI
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clavien-Dindo Grade <IV Complications | Cost | 30363 Euros | Standard Deviation 12701 |
| Clavien-Dindo Grade ≥IV Complications | Cost | 83329 Euros | Standard Deviation 86120 |
Secondary
Hospital Stay
The patient hospital stay was calculated according to the total number of days the patient was hospitalized.
Time frame: December 2010
Population: According to MRI
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Clavien-Dindo Grade <IV Complications | Hospital Stay | 12 days |
| Clavien-Dindo Grade ≥IV Complications | Hospital Stay | 19 days |
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.
Time frame: December 2010
Population: According to MRI
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Clavien-Dindo Grade <IV Complications | Intensive Care Unit (ICU) Stay | 1 days |
| Clavien-Dindo Grade ≥IV Complications | Intensive Care Unit (ICU) Stay | 2 days |
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.
Time frame: December 2010
Population: According to MRI
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Clavien-Dindo Grade <IV Complications | Intra-operative Blood Loss | 300 ml |
| Clavien-Dindo Grade ≥IV Complications | Intra-operative Blood Loss | 400 ml |
Secondary
Operative Time
The operation duration was measured according to the total minutes from the beginning of the operation until the end.
Time frame: December 2010
Population: According to MRI
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Clavien-Dindo Grade <IV Complications | Operative Time | 323 min |
| Clavien-Dindo Grade ≥IV Complications | Operative Time | 360 min |
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.
Time frame: December 2010
Population: According to the MRI liver fat content measurement.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Clavien-Dindo Grade <IV Complications | Post-operative Alanine Transaminase (ALT) Levels | 386 Units/liter |
| Clavien-Dindo Grade ≥IV Complications | Post-operative Alanine Transaminase (ALT) Levels | 1355 Units/liter |
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.
Time frame: December 2010