Right Hepatectomy in Patients Beyond 70 Years Old

Complications Clinical Trial

Official title:

Right and Extended Right Hepatectomy in Patients Beyond 70 Years of Age - Liver Function and Outcome

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01471262
• Other study ID #: CHV080501
• 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

• Complications
• Liver Failure
• Liver Failure, Acute

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