Trial Outcomes & Findings for Liver Fat Quantification by Magnetic Resonance Imaging (MRI) - Prediction of Postoperative Complications (NCT NCT01234714)

Results Overview

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

Recruitment status

COMPLETED

Target enrollment

84 participants

Primary outcome timeframe

December 2010

Results posted on

2012-02-08

Participant Flow

Patients that underwent liver surgery were recruited at the outpatient clinics.

Participant milestones

Participant milestones
Measure	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).
Overall Study STARTED	84
Overall Study COMPLETED	84
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Liver Fat Quantification by Magnetic Resonance Imaging (MRI) - Prediction of Postoperative Complications

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Major Liver Resection n=84 Participants This single Cohort/Group will include all consecutive patients that received pre-operative Magnetic Resonant Imaging (MRI) and underwent major liver resection (\>=3 segments).
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	67 Participants n=5 Participants
Age, Categorical >=65 years	17 Participants n=5 Participants
Age Continuous	54 years STANDARD_DEVIATION 15 • n=5 Participants
Sex: Female, Male Female	40 Participants n=5 Participants
Sex: Female, Male Male	44 Participants n=5 Participants
Region of Enrollment Switzerland	84 participants n=5 Participants

PRIMARY outcome

Timeframe: December 2010

Population: According to the Clavien-Dindo Classification of surgical complications: (please see) http://www.surgicalcomplication.info/

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

Outcome measures

Outcome measures
Measure	Clavien-Dindo Grade <IV Complications n=75 Participants Percentage of liver fat content on MRI in patients with Clavien-Dindo Grade \<IV complications. No complications: Patients without any post-operative complications defined according to the Clavien-Dindo Classification. Grade 1: Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions. Allowed therapeutic regimens are: drugs as antiemetics, antipyretics, analgetics, diuretics and electrolytes and physiotherapy. This grade also includes wound infections opened at the bedside. Grade II: Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Blood transfusions and total parenteral nutrition are also included. Grade III:Requiring surgical, endoscopic or radiological intervention	Clavien-Dindo Grade ≥IV Complications n=9 Participants Percentage of liver fat content on MRI in patients with Clavien-Dindo Grade \<IV complications. These are typically life-threatening complication (including CNS complications) requiring ICU management. Grade IVa: single organ dysfunction (including dialysis) Grade IVb: multi-organ dysfunction
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 Interval 0.5 to 4.2	13.6 Percentage of liver fat content Interval 7.6 to 18.9

SECONDARY outcome

Timeframe: December 2010

Population: According to the MRI liver fat content measurement.

Alanine Transaminase is commonly measured clinically as a part of a diagnostic evaluation of hepatocellular injury, to determine liver health.

Outcome measures

Outcome measures
Measure	Clavien-Dindo Grade <IV Complications n=69 Participants Percentage of liver fat content on MRI in patients with Clavien-Dindo Grade \<IV complications. No complications: Patients without any post-operative complications defined according to the Clavien-Dindo Classification. Grade 1: Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions. Allowed therapeutic regimens are: drugs as antiemetics, antipyretics, analgetics, diuretics and electrolytes and physiotherapy. This grade also includes wound infections opened at the bedside. Grade II: Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Blood transfusions and total parenteral nutrition are also included. Grade III:Requiring surgical, endoscopic or radiological intervention	Clavien-Dindo Grade ≥IV Complications n=15 Participants Percentage of liver fat content on MRI in patients with Clavien-Dindo Grade \<IV complications. These are typically life-threatening complication (including CNS complications) requiring ICU management. Grade IVa: single organ dysfunction (including dialysis) Grade IVb: multi-organ dysfunction
Post-operative Alanine Transaminase (ALT) Levels	386 Units/liter Interval 262.0 to 486.0	1355 Units/liter Interval 1277.0 to 1894.0

SECONDARY outcome

Timeframe: December 2010

Population: According to MRI

Intra-operative blood loss was defined according to the total volume of blood loss from the beginning until the end of the operation.

Outcome measures

Outcome measures
Measure	Clavien-Dindo Grade <IV Complications n=69 Participants Percentage of liver fat content on MRI in patients with Clavien-Dindo Grade \<IV complications. No complications: Patients without any post-operative complications defined according to the Clavien-Dindo Classification. Grade 1: Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions. Allowed therapeutic regimens are: drugs as antiemetics, antipyretics, analgetics, diuretics and electrolytes and physiotherapy. This grade also includes wound infections opened at the bedside. Grade II: Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Blood transfusions and total parenteral nutrition are also included. Grade III:Requiring surgical, endoscopic or radiological intervention	Clavien-Dindo Grade ≥IV Complications n=15 Participants Percentage of liver fat content on MRI in patients with Clavien-Dindo Grade \<IV complications. These are typically life-threatening complication (including CNS complications) requiring ICU management. Grade IVa: single organ dysfunction (including dialysis) Grade IVb: multi-organ dysfunction
Intra-operative Blood Loss	300 ml Interval 200.0 to 500.0	400 ml Interval 300.0 to 600.0

SECONDARY outcome

Timeframe: December 2010

Population: According to MRI

The operation duration was measured according to the total minutes from the beginning of the operation until the end.

Outcome measures

Outcome measures
Measure	Clavien-Dindo Grade <IV Complications n=69 Participants Percentage of liver fat content on MRI in patients with Clavien-Dindo Grade \<IV complications. No complications: Patients without any post-operative complications defined according to the Clavien-Dindo Classification. Grade 1: Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions. Allowed therapeutic regimens are: drugs as antiemetics, antipyretics, analgetics, diuretics and electrolytes and physiotherapy. This grade also includes wound infections opened at the bedside. Grade II: Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Blood transfusions and total parenteral nutrition are also included. Grade III:Requiring surgical, endoscopic or radiological intervention	Clavien-Dindo Grade ≥IV Complications n=15 Participants Percentage of liver fat content on MRI in patients with Clavien-Dindo Grade \<IV complications. These are typically life-threatening complication (including CNS complications) requiring ICU management. Grade IVa: single organ dysfunction (including dialysis) Grade IVb: multi-organ dysfunction
Operative Time	323 min Interval 240.0 to 405.0	360 min Interval 300.0 to 420.0

SECONDARY outcome

Timeframe: December 2010

Population: According to MRI

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.

Outcome measures

Outcome measures
Measure	Clavien-Dindo Grade <IV Complications n=69 Participants Percentage of liver fat content on MRI in patients with Clavien-Dindo Grade \<IV complications. No complications: Patients without any post-operative complications defined according to the Clavien-Dindo Classification. Grade 1: Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions. Allowed therapeutic regimens are: drugs as antiemetics, antipyretics, analgetics, diuretics and electrolytes and physiotherapy. This grade also includes wound infections opened at the bedside. Grade II: Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Blood transfusions and total parenteral nutrition are also included. Grade III:Requiring surgical, endoscopic or radiological intervention	Clavien-Dindo Grade ≥IV Complications n=15 Participants Percentage of liver fat content on MRI in patients with Clavien-Dindo Grade \<IV complications. These are typically life-threatening complication (including CNS complications) requiring ICU management. Grade IVa: single organ dysfunction (including dialysis) Grade IVb: multi-organ dysfunction
Intensive Care Unit (ICU) Stay	1 days Interval 1.0 to 1.0	2 days Interval 1.0 to 13.0

SECONDARY outcome

Timeframe: December 2010

Population: According to MRI

The patient hospital stay was calculated according to the total number of days the patient was hospitalized.

Outcome measures

Outcome measures
Measure	Clavien-Dindo Grade <IV Complications n=69 Participants Percentage of liver fat content on MRI in patients with Clavien-Dindo Grade \<IV complications. No complications: Patients without any post-operative complications defined according to the Clavien-Dindo Classification. Grade 1: Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions. Allowed therapeutic regimens are: drugs as antiemetics, antipyretics, analgetics, diuretics and electrolytes and physiotherapy. This grade also includes wound infections opened at the bedside. Grade II: Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Blood transfusions and total parenteral nutrition are also included. Grade III:Requiring surgical, endoscopic or radiological intervention	Clavien-Dindo Grade ≥IV Complications n=15 Participants Percentage of liver fat content on MRI in patients with Clavien-Dindo Grade \<IV complications. These are typically life-threatening complication (including CNS complications) requiring ICU management. Grade IVa: single organ dysfunction (including dialysis) Grade IVb: multi-organ dysfunction
Hospital Stay	12 days Interval 10.0 to 16.0	19 days Interval 14.0 to 31.0

SECONDARY outcome

Timeframe: December 2010

Population: According to MRI

The total in-hospital costs were calculated for each patient in Euros.

Outcome measures

Outcome measures
Measure	Clavien-Dindo Grade <IV Complications n=69 Participants Percentage of liver fat content on MRI in patients with Clavien-Dindo Grade \<IV complications. No complications: Patients without any post-operative complications defined according to the Clavien-Dindo Classification. Grade 1: Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions. Allowed therapeutic regimens are: drugs as antiemetics, antipyretics, analgetics, diuretics and electrolytes and physiotherapy. This grade also includes wound infections opened at the bedside. Grade II: Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Blood transfusions and total parenteral nutrition are also included. Grade III:Requiring surgical, endoscopic or radiological intervention	Clavien-Dindo Grade ≥IV Complications n=15 Participants Percentage of liver fat content on MRI in patients with Clavien-Dindo Grade \<IV complications. These are typically life-threatening complication (including CNS complications) requiring ICU management. Grade IVa: single organ dysfunction (including dialysis) Grade IVb: multi-organ dysfunction
Cost	30363 Euros Standard Deviation 12701	83329 Euros Standard Deviation 86120

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

Adverse Events

Major Liver Resection

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Dimitri Aristotle Raptis, Principal Investigator

University of Zurich

Phone: +41442553300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place