Fatty LiverMRsteatosisNCT01234714
Liver Fat Quantification by Magnetic Resonance Imaging (MRI) - Prediction of Postoperative Complications
An observational study of Fatty Liver and Surgery, run by University of Zurich at 2 sites in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Fatty Liver, Surgery
- What is being tested?
- Non-invasive Magnetic Resonance Imaging (MRI) and Major liver resection
- Type of treatment
- Surgery or procedure
- How many people
- 84 participants
- Where
- 2 sitesSwitzerland
- Study dates
- Oct 2010to Jul 2011
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care clinics
Who may be able to join
- Major liver resection (>= 3 resected segments).
- Patients that received a pre-operative Magnetic Resonance Imaging (MRI).
- Patient over 18 years of age
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
University Hospital Zurich, Department of Interventional and Diagnostic Radiology
Zurich, Canton of Zurich, 8091
University Hospital Zurich, Department of Visceral and Transplant Surgery, Swiss Hepato-Pancreato-Biliary (HPB) Center
Zurich, Canton of Zurich, 8091
About this study
Official title: Liver Fat Quantification by Magnetic Resonance Imaging (MRI): A Novel Tool for Prediction of Postoperative Complications After Major Liver Resection?
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.
Read the 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.
- Conditions
- Fatty Liver, Surgery
- Being tested
- Non-invasive Magnetic Resonance Imaging (MRI), Major liver resection
- Keywords
- Fatty Liver, Liver, Magnetic Resonance Imaging, Surgery
- Medical subject headings
- Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive Magnetic Resonance Imaging (MRI)Other
Also called Magnetic Resonance Imaging
Conventional pre-operative MRI
Major liver resectionProcedure or surgery
Also called Hepatectomy = liver resection by open surgery.
Hepatectomy of >= 3 liver segments
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Non-invasive Magnetic Resonance Imaging (MRI); Procedure: Major liver resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: December 2010
Secondary outcomes (7)
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.
Measured: December 2010
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.
Measured: December 2010
Operative Time
The operation duration was measured according to the total minutes from the beginning of the operation until the end.
Measured: December 2010
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.
Measured: December 2010
Hospital Stay
The patient hospital stay was calculated according to the total number of days the patient was hospitalized.
Measured: December 2010
Cost
The total in-hospital costs were calculated for each patient in Euros.
Measured: December 2010
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.
Measured: December 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2010 (estimated)
- Study startOct 2010
- Primary completionDec 2010
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Fatty LiverStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dimitri A Raptis, MD, MSc, Principal investigator, University Hospital Zurich, Department of Visceral and Transplant Surgery, Zurich, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01234714
- Sponsor's protocol ID
- MRI_Steatosis_Outcomes
- Acronym
- MRsteatosis
- Status last verified
- Feb 2012
- First submitted
- 3 Nov 2010
- Last updated
- 8 Feb 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 19638912Raptis 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.
PubMed 21997548
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liver Fat Quantification by Magnetic Resonance Imaging (MRI): A Novel Tool for Prediction of Postoperative Complications After Major Liver Resection?
- ClinicalTrials.gov ID
- NCT01234714
- Acronym / sponsor ID
- MRsteatosis / MRI_Steatosis_Outcomes
- Conditions
- Fatty Liver, Surgery
- Keywords
- Fatty Liver, Liver, Magnetic Resonance Imaging, Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 4 Nov 2010 (estimated)
- Results
- Posted 8 Feb 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Major liver resection | – | Other: Non-invasive Magnetic Resonance Imaging (MRI), Procedure: Major liver resectionThis single Cohort/Group will include all consecutive patients that received pre-operative Magnetic Resonant Imaging (MRI) and underwent major liver resection (>=3 segments). |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinics
Key inclusion criteria (3 listed)
- Major liver resection (>= 3 resected segments).
- Patients that received a pre-operative Magnetic Resonance Imaging (MRI).
- Patient over 18 years of age
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-invasive Magnetic Resonance Imaging (MRI)Also: Magnetic Resonance ImagingConventional pre-operative MRI | Other | Major liver resection |
| Major liver resectionAlso: Hepatectomy = liver resection by open surgery.Hepatectomy of >= 3 liver segments | Procedure or surgery | Major liver resection |
Primary outcome
Percentage of Liver Fat Content on MRI in Patients With Serious Post-operative Complications (Clavien-Dindo Grade ≥IV)
Time frame: 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
7 secondary outcomes
Post-operative Alanine Transaminase (ALT) Levels
Time frame: December 2010
Intra-operative Blood Loss
Time frame: December 2010
Operative Time
Time frame: December 2010
Intensive Care Unit (ICU) Stay
Time frame: December 2010
Hospital Stay
Time frame: December 2010
Cost
Time frame: December 2010
Type of Post-operative Complications
Time frame: December 2010
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19638912Clavien 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.
- Results publication: PubMed 21997548Raptis 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dimitri A Raptis, MD, MSc principal investigator
University Hospital Zurich, Department of Visceral and Transplant Surgery, Zurich, Switzerland
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fatty Liver and Surgery, run by University of Zurich at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Feb 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Liver Fat Content on MRI in Patients With Serious Post-operative Complications (Clavien-Dindo Grade ≥IV) (time frame: December 2010). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01234714, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2012.