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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT01471262
Other study ID # CHV080501
Secondary ID
Status Enrolling by invitation
Phase N/A
First received November 10, 2011
Last updated November 21, 2011
Start date January 2006
Est. completion date December 2011

Study information

Verified date November 2011
Source Centre Hospitalier Universitaire Vaudois
Contact n/a
Is FDA regulated No
Health authority Switzerland: Ethikkommission
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 90
Est. completion date December 2011
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Age >= 18 years

- Elective right hepatectomy

- Elective extended right hepatectomy

Exclusion Criteria:

- Age < 18 years

- Pregnancy

- Other type of hepatectomy

- Emergency hepatectomy

Study Design

Observational Model: Case Control, Time Perspective: Retrospective


Related Conditions & MeSH terms


Intervention

Procedure:
Right hepatectomy
Right liver resection
Extended right hepatectomy
Right hepatectomy involving 5 or more segments

Locations

Country Name City State
Switzerland Department of Visceral Surgery, University Hospital CHUV Lausanne

Sponsors (2)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire Vaudois 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

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Morbidity Any type of complication defined according to the Clavien-Dindo Classification of surgical complications. 90 days Yes
Secondary Mortality Patient death occuring 90 days post-operatively 90 days Yes
Secondary Liver failure Defined according to the Belghiti 50-50 criteria for liver failure. 90 days Yes
Secondary Hospital stay Total hospital stay (including re-admission hospital stay) in days 90 days No
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