NCT01234714

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2010

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 3, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 2010

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
7 months until next milestone

Results Posted

Study results publicly available

February 8, 2012

Completed
Last Updated

February 8, 2012

Status Verified

February 1, 2012

Enrollment Period

2 months

First QC Date

November 3, 2010

Results QC Date

November 11, 2011

Last Update Submit

February 7, 2012

Conditions

Fatty LiverSurgery

Keywords

Fatty LiverLiverMagnetic Resonance ImagingSurgery

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (7)

  • Post-operative Alanine Transaminase (ALT) Levels

    December 2010

  • Intra-operative Blood Loss

    December 2010

  • Operative Time

    December 2010

  • Intensive Care Unit (ICU) Stay

    December 2010

  • Hospital Stay

    December 2010

  • +2 more secondary outcomes

Study Arms (1)

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).

Other: Non-invasive Magnetic Resonance Imaging (MRI)Procedure: Major liver resection

Interventions

Non-invasive Magnetic Resonance Imaging (MRI)OTHER

Conventional pre-operative MRI

Also known as: Magnetic Resonance Imaging
Major liver resection
Major liver resectionPROCEDURE

Hepatectomy of \>= 3 liver segments

Also known as: Hepatectomy = liver resection by open surgery.
Major liver resection

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary care clinics

You may qualify if:

  • Major liver resection (\>= 3 resected segments).
  • Patients that received a pre-operative Magnetic Resonance Imaging (MRI).
  • Patient over 18 years of age

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospital Zurich, Department of Interventional and Diagnostic Radiology

Zurich, Canton of Zurich, 8091, Switzerland

Location

University Hospital Zurich, Department of Visceral and Transplant Surgery, Swiss Hepato-Pancreato-Biliary (HPB) Center

Zurich, Canton of Zurich, 8091, Switzerland

Location

Related Publications (2)

  • 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.

    PMID: 19638912BACKGROUND

  • 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.

    PMID: 21997548RESULT

MeSH Terms

Conditions

Fatty Liver

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Results Point of Contact

Title
Dr Dimitri Aristotle Raptis, Principal Investigator
Organization
University of Zurich
dimitri.raptis@usz.ch
+41442553300

Study Officials

  • Dimitri A Raptis, MD, MSc

    University Hospital Zurich, Department of Visceral and Transplant Surgery, Zurich, Switzerland

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2010

First Posted

November 4, 2010

Study Start

October 1, 2010

Primary Completion

December 1, 2010

Study Completion

July 1, 2011

Last Updated

February 8, 2012

Results First Posted

February 8, 2012

Record last verified: 2012-02

Locations

CH(2)