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

Surgery Clinical Trial

— MRsteatosis  

Official title:

Liver Fat Quantification by Magnetic Resonance Imaging (MRI): A Novel Tool for Prediction of Postoperative Complications After Major Liver Resection?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01234714
• Other study ID #: MRI_Steatosis_Outcomes
• Status: Completed
• Phase: N/A
• First received: November 3, 2010
• Last updated: February 7, 2012
• Start date: October 2010
• Est. completion date: July 2011

Study information

• Verified date: February 2012
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: July 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Fatty Liver
• Postoperative Complications
• Surgery

Intervention

Other:
• Non-invasive Magnetic Resonance Imaging (MRI)
Conventional pre-operative MRI

Procedure:
• Major liver resection
Hepatectomy of >= 3 liver segments

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich, Department of Interventional and Diagnostic Radiology	Zurich
Switzerland	University Hospital Zurich, Department of Visceral and Transplant Surgery, Swiss Hepato-Pancreato-Biliary (HPB) Center	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

References & Publications (2)

Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibañes 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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	December 2010	Yes
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.	December 2010	No
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.	December 2010	No
Secondary	Operative Time	The operation duration was measured according to the total minutes from the beginning of the operation until the end.	December 2010	No
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.	December 2010	No
Secondary	Hospital Stay	The patient hospital stay was calculated according to the total number of days the patient was hospitalized.	December 2010	No
Secondary	Cost	The total in-hospital costs were calculated for each patient in Euros.	December 2010	No
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.	December 2010	Yes

External Links

•   The Clavien-Dindo Classification of Surgical Complications