Right Hepatectomy in Patients Beyond 70 Years Old

November 21, 2011 updated by: Dr. Emmanuel Melloul, Centre Hospitalier Universitaire Vaudois

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Lausanne, Switzerland, CH-1012
        • Department of Visceral Surgery, University Hospital CHUV

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Elderly
Patients more or equal to 70 years old
Procedure: Right hepatectomy
Right liver resection
Other Names:
  • Liver surgery
Procedure: Extended right hepatectomy
Right hepatectomy involving 5 or more segments
Other Names:
  • Liver surgery
Young
Patients less than 70 years old
Procedure: Right hepatectomy
Right liver resection
Other Names:
  • Liver surgery
Procedure: Extended right hepatectomy
Right hepatectomy involving 5 or more segments
Other Names:
  • Liver surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morbidity
Time Frame: 90 days
Any type of complication defined according to the Clavien-Dindo Classification of surgical complications.
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 90 days
Patient death occuring 90 days post-operatively
90 days
Liver failure
Time Frame: 90 days
Defined according to the Belghiti 50-50 criteria for liver failure.
90 days
Hospital stay
Time Frame: 90 days
Total hospital stay (including re-admission hospital stay) in days
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Vaudois

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Anticipated)

December 1, 2011

Study Completion (Anticipated)

December 1, 2011

Study Registration Dates

First Submitted

November 10, 2011

First Submitted That Met QC Criteria

November 14, 2011

First Posted (Estimate)

November 15, 2011

Study Record Updates

Last Update Posted (Estimate)

November 22, 2011

Last Update Submitted That Met QC Criteria

November 21, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHV080501

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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