Clinical trial NCT01234714: Liver Fat Quantification by Magnetic Resonance Imaging (MRI) - Prediction of Postoperative Complications
Official title: Liver Fat Quantification by Magnetic Resonance Imaging (MRI): A Novel Tool for Prediction of Postoperative Complications After Major Liver Resection?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fatty Liver
Surgery
Keywords: Fatty Liver
Liver
Magnetic Resonance Imaging
Surgery
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2010-11-04
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinics

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Liver Fat Content on MRI in Patients With Serious Post-operative Complications (Clavien-Dindo Grade ≥IV)
timeFrame: December 2010
Secondary outcomes:
measure: Post-operative Alanine Transaminase (ALT) Levels
timeFrame: December 2010
measure: Intra-operative Blood Loss
timeFrame: December 2010
measure: Operative Time
timeFrame: December 2010
measure: Intensive Care Unit (ICU) Stay
timeFrame: December 2010
measure: Hospital Stay
timeFrame: December 2010
measure: Cost
timeFrame: December 2010
measure: Type of Post-operative Complications
timeFrame: December 2010
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Department of Interventional and Diagnostic Radiology
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Department of Visceral and Transplant Surgery, Swiss Hepato-Pancreato-Biliary (HPB) Center
Study officials:
affiliation: University Hospital Zurich, Department of Visceral and Transplant Surgery, Zurich, Switzerland
name: Dimitri A Raptis, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.