NCT01471262

Brief Summary

As a consequence of the increase in life expectancy, hepato-biliary surgeons have to deal with an emerging aged population, which has a potential higher risk for complication and worse long-term outcome. The investigators will be analyzing the liver function and outcome after right or extended right hepatectomy in patients over 70 years old.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2006

Completed
5.9 years until next milestone

First Submitted

Initial submission to the registry

November 10, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 15, 2011

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

November 22, 2011

Status Verified

November 1, 2011

Enrollment Period

5.9 years

First QC Date

November 10, 2011

Last Update Submit

November 21, 2011

Conditions

ComplicationsLiver Failure, Acute

Keywords

ComplicationsMortalityLiverFailure

Outcome Measures

Primary Outcomes (1)

  • Morbidity

    Any type of complication defined according to the Clavien-Dindo Classification of surgical complications.

    90 days

Secondary Outcomes (3)

  • Mortality

    90 days

  • Liver failure

    90 days

  • Hospital stay

    90 days

Study Arms (2)

Elderly

Patients more or equal to 70 years old

Procedure: Right hepatectomyProcedure: Extended right hepatectomy

Young

Patients less than 70 years old

Procedure: Right hepatectomyProcedure: Extended right hepatectomy

Interventions

Right hepatectomyPROCEDURE

Right liver resection

Also known as: Liver surgery
ElderlyYoung
Extended right hepatectomyPROCEDURE

Right hepatectomy involving 5 or more segments

Also known as: Liver surgery
ElderlyYoung

Eligibility Criteria

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

All patients that will undergo right or extended right hepatectomy for benign or malignant diseases.

You may qualify if:

  • Age \>= 18 years
  • Elective right hepatectomy
  • Elective extended right hepatectomy

You may not qualify if:

  • Age \< 18 years
  • Pregnancy
  • Other type of hepatectomy
  • Emergency hepatectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Visceral Surgery, University Hospital CHUV

Lausanne, CH-1012, 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

  • Paugam-Burtz C, Janny S, Delefosse D, Dahmani S, Dondero F, Mantz J, Belghiti J. Prospective validation of the "fifty-fifty" criteria as an early and accurate predictor of death after liver resection in intensive care unit patients. Ann Surg. 2009 Jan;249(1):124-8. doi: 10.1097/SLA.0b013e31819279cd.

    PMID: 19106687BACKGROUND

MeSH Terms

Conditions

Liver Failure, Acute

Condition Hierarchy (Ancestors)

Liver FailureHepatic InsufficiencyLiver DiseasesDigestive System Diseases

Study Officials

  • Emmanuel Melloul, MD

    Department of Visceral Surgery, University Hospital CHUV, Lausanne, Switzerland

    PRINCIPAL INVESTIGATOR

  • Nicolas Demartines, MD

    Department of Visceral Surgery, University Hospital CHUV, Lausanne, Switzerland

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

November 10, 2011

First Posted

November 15, 2011

Study Start

January 1, 2006

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

November 22, 2011

Record last verified: 2011-11

Locations

CH(1)