Trial document





This trial has been registered retrospectively.
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  DRKS00006160

Trial Description

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Title

Value of a preoperative volume/ function analysis for patient safety after extended partial liver resection

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Trial Acronym

FUSION

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URL of the Trial

http://www.charite.de/avt/forschung/workgroup_for_the_liver/ongoing-projects.html

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Brief Summary in Lay Language

Improvement in operative mortality rates after hepatic tumour resection has broadened its use for the treatment of patients with benign and malign hepatobiliary disease. Extended resection has evolved as a suitable approach to ensure entire tumour resection in selected patients and previous large series demonstrated higher survival rates compared to non-surgical strategies. In consequence radical approaches in non-cirrhotic livers with resulting smaller remnant volumes have become more frequent.However, pre-existing hepatic dysfunction is a major cause for concerns when treating such patients and the selection criteria to identify candidates, in whom a surgical intervention can be safely performed, remain ill defined.
Herein we examine the value and the reliability of a preoperative volume/ function analysis (CT-imaging and liver function testing) in a monocentric prospective study. In consequence we compare preoeprative estimated values (future remnant function / future remnant volume) with postoperative present values (remnant function/ remnant volume). Beyond that we are aiming to determine (functional) liver regeneration in the postoperative course and analyze patients outcome.

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Brief Summary in Scientific Language

We are aiming to evaluate reliability of preoperative volume/function analysis before liver surgery by comparing estimated values with direct postoperative measured values of remnant liver function and remnant liver volume. In this monocentric prospecitv clinical study patients (age greater 50) planned for oncologic liver surgery at the Charité - Universitätsmedizin Berlin undergo liver specific testings (blood analyiss and enzymatic liver function testing - LiMAx). Combined with a preoperative CT-imaging (study date: max. 4 weeks prior inclusion) future remnant liver function and future remnant liver volume is estimated by means of a 3D- operation planning the day before surgery. Repeat CT-imaging and LiMAx examination direct post surgery will reveal present values.
In the postoperative course (functional) liver regeneration is determined by means of repeat blood tests and LiMAx examinations until postoperative day 90. We recode postoperative morbididy and mortality and individual clinical course.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00006160
  •   2014/05/14
  •   [---]*
  •   yes
  •   Approved
  •   EA2/080/08, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

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Health Condition or Problem studied

  •   C22.0 -  Malignant neoplasm: Liver cell carcinoma
  •   C22.1 -  Malignant neoplasm: Intrahepatic bile duct carcinoma
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Interventions/Observational Groups

  •   40 female or male patients (age greater 50) which are undergoing an oncologic partial liver resection an our department. In the frame of this study we measure preoperative liver function (surrogate blood parameters and LiMAx, a specific enzymatic liver function test). Beyond that we analyze Liver perfusion noninvasively by means of doppler ultrasound. By means of a preoperative volume-/function analysis remnant liver function is estimated (3D operation planning). The CT imaging needs to be performed within 4 weeks prior study enrolment. Postoperatively estimates are confirmed by liver function testing and repeat CT examination. In the postoperative course liver regeneration is determined by liver tests on postoperative day 1/3/5/10/14/ asnd 90.
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Evaluation of the reliability of preoperative evaluation of future remnant liver volume and future remnant liver function by comparison to really measured postoperative values.

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Secondary Outcome

Evaluation of perioperative factors associated with morbidity and mortality with respect to remnant volume and remnant liver function

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2008/10/18
  •   40
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   50   Years
  •   no maximum age
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Additional Inclusion Criteria

- Patients suffering from maligne hepatobiliary disease
- preoperative CT-imaging (examination date: max. 4 weeks prior inclusion)
- informed consent

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Exclusion Criteria

-Patients with previous liver surgery
- Impaired renal function (elevated serum creatinine)
- Contrast medium intolerance
- Thyroid hypofunction (decreased TSH)

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Addresses

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    • Charité - Universitätsmedizin Berlin
    • Mr.  Priv.-Doz. Dr. med.  Martin  Stockmann 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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    • Jara Charité - Universitätsmedizin Berlin
    • Mr.  Dr. med. univ.  Maximilian  Jara 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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    • Charité - Universitätsmedizin Berlin
    • Mr.  Priv.-Doz. Dr. med.  Martin  Stockmann 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Charité Campus Virchow-Klinikum
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.