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Right Hepatectomy in Patients Beyond 70 Years Old

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
University of Zurich
Information provided by (Responsible Party):
Dr. Emmanuel Melloul, Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier:
NCT01471262
First received: November 10, 2011
Last updated: November 21, 2011
Last verified: November 2011
History of Changes
  Purpose

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.


Condition Intervention
Complications
Liver Failure, Acute
 Procedure: Right hepatectomy
Procedure: Extended right hepatectomy

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Right and Extended Right Hepatectomy in Patients Beyond 70 Years of Age - Liver Function and Outcome

Further study details as provided by Centre Hospitalier Universitaire Vaudois:

Primary Outcome Measures:
  • Morbidity [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
    Any type of complication defined according to the Clavien-Dindo Classification of surgical complications.


Secondary Outcome Measures:
  • Mortality [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
    Patient death occuring 90 days post-operatively

  • Liver failure [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
    Defined according to the Belghiti 50-50 criteria for liver failure.

  • Hospital stay [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    Total hospital stay (including re-admission hospital stay) in days


Estimated Enrollment: 90
Study Start Date: January 2006
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Elderly
Patients more or equal to 70 years old
 Procedure: Right hepatectomy
Right liver resection
Other Name: Liver surgery
Procedure: Extended right hepatectomy
Right hepatectomy involving 5 or more segments
Other Name: Liver surgery
Young
Patients less than 70 years old
 Procedure: Right hepatectomy
Right liver resection
Other Name: Liver surgery
Procedure: Extended right hepatectomy
Right hepatectomy involving 5 or more segments
Other Name: Liver surgery

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Age < 18 years
  • Pregnancy
  • Other type of hepatectomy
  • Emergency hepatectomy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01471262

Locations
Switzerland
Department of Visceral Surgery, University Hospital CHUV
Lausanne, Switzerland, CH-1012
Sponsors and Collaborators
Centre Hospitalier Universitaire Vaudois
University of Zurich
Investigators
Principal Investigator: Emmanuel Melloul, MD Department of Visceral Surgery, University Hospital CHUV, Lausanne, Switzerland
Study Chair: Nicolas Demartines, MD Department of Visceral Surgery, University Hospital CHUV, Lausanne, Switzerland
  More Information

Publications:

Responsible Party: Dr. Emmanuel Melloul, Medical Doctor, Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier: NCT01471262     History of Changes
Other Study ID Numbers: CHV080501
Study First Received: November 10, 2011
Last Updated: November 21, 2011
Health Authority: Switzerland: Ethikkommission

Keywords provided by Centre Hospitalier Universitaire Vaudois:
Complications
Mortality
Liver
Failure

Additional relevant MeSH terms:
Liver Failure
Liver Failure, Acute
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 16, 2013