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Trial record 30 of 41 for:    "Klatskin tumor"

Optimization of Health Expenditure in Liver Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01715402
Recruitment Status : Unknown
Verified February 2017 by Centre Hospitalier Universitaire, Amiens.
Recruitment status was:  Enrolling by invitation
First Posted : October 29, 2012
Last Update Posted : February 6, 2017
Assistance Publique - Hôpitaux de Paris
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

Brief Summary:
The aim of this study is to reduce the length of stay after liver surgery by taking account of objective quantitative clinical variables, subjective qualitative clinical variables and non clinical variables.

Condition or disease Intervention/treatment
Hepatocellular Carcinoma Hilar Cholangiocarcinoma Intra Hepatic Cholangiocarcinoma Liver Metastasis Procedure: liver surgery

Detailed Description:

a new dimension of the activity expected of physicians is to improve the safety of care on the one hand and the control of health care costs on the other.

key measures to help them are the publication of national recommendations, assessment of actual practices and the incentive to activity.

Internationalwide recent and concordant data suggest that

  • quality and security of care, after an initial improvement, are going to stall
  • scientific recommendations are rarely validated by an impact analysis and are not applied
  • clinical data collected within an administrative framework are unreliable and too generalist
  • the evaluation, especially in the surgical field, is based on indicators sometimes irrelevant and often unclear

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Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Optimization of Health Expenditure in Major Surgery: Impact of a Mixed, Clinical and Ethnographic Approach in the Model of Liver Surgery
Actual Study Start Date : September 2012
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018

Group/Cohort Intervention/treatment
operated patients
this cohort includes patients who underwent a liver surgery whatever the pathology and whatever the surgical procedure
Procedure: liver surgery
this intervention type includes hepatectomies; wedge; segmentectomies etc...

Primary Outcome Measures :
  1. overall postoperative length of stay [ Time Frame: during the 3 months after the surgery ]

    the overall postoperative length of stay is defined as the hospitalization between the surgery and patient's discharge.

    This period includes the readmission for at least 24 hours in case of outcomes related to the surgery.

Secondary Outcome Measures :
  1. peroperative outcomes [ Time Frame: during the surgical procedure ]
    the peroperative outcomes are collected during the surgery and correspond to any event occured during the surgical intervention

  2. postoperative outcomes [ Time Frame: after the surgery until postoperative month 3 ]
    the postoperative outcomes correspond to any event occured after the surgical intervention. These outcomes include fistulae; bleeding...

  3. construct of pronostic models [ Time Frame: after the postoperative month 3 ]
    the construct of pronostic models include variables that affect the length of stay; morbidity and mortality

  4. evaluation of PMSI indicators [ Time Frame: after the postoperative month 3 ]
    this evaluation includes the analysis of PMSI indicators; their validity and the influence of centres on hepatectomies results

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

the population corresponds to patients operated in one of the thirteen hospitals.

These hospitals are distributed on the french territory to ensure that the recruitment is representative of the general population


Inclusion Criteria:

  • elective liver surgery
  • older than 18
  • agreed to participate
  • surgical procedure included procedures registered as "HLFA003 - 007 ; 009 - 011 ; 017 - 020 ; HLFC002 à 004 ; 027 ; 032 ; 037" in the PMSI database

Exclusion Criteria:

  • emergency surgery
  • refused to participate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01715402

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Amiens North Hospital
Amiens, France
Bordeaux Hospital
Bordeaux, France
Beaujon University Hospital
Clichy, France
Lille Regional Hospital
Lille, France
Lyon Hospital
Lyon, France
Marseille Hospital
Marseille, France
Paoli calmette institute
Marseille, France
Saint Antoine Hospital
Paris, France
Strasbourg hospital
Strasbourg, France
Gustave Roussy institute
Villejuif, France
Paul Brousse Hospital
Villejuif, France
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Assistance Publique - Hôpitaux de Paris
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Principal Investigator: Olivier FARGES, MD, phD Beaujon University Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Centre Hospitalier Universitaire, Amiens Identifier: NCT01715402     History of Changes
Other Study ID Numbers: AOM 11060
First Posted: October 29, 2012    Key Record Dates
Last Update Posted: February 6, 2017
Last Verified: February 2017

Keywords provided by Centre Hospitalier Universitaire, Amiens:
liver tumor

Additional relevant MeSH terms:
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Klatskin Tumor
Neoplasm Metastasis
Carcinoma, Hepatocellular
Neoplastic Processes
Pathologic Processes
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Liver Extracts