Trial document




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  DRKS00019201

Trial Description

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Title

EsoHep - Evaluation of liver function for perioperative risk assessment in patients with esophageal carcinoma

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Trial Acronym

EsoHep

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Esophageal resection is an invasive operation with a comparatively high risk of damage to the patients. Therefore, it is crucial to select the patients with specific test prior to surgery. Liver function is central for healing after every major surgery. The aim of this study is a comparative testing of the available liver function test to find a reliable marker for patient selection. The next step would be to evaluate whether it is possible to predict complications with this preoperative measurement.

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Brief Summary in Scientific Language

Due to the invasiveness and the extent of the surgical trauma, it is crucial to have a preoperative assessment and a risk evaluation prior to performing an esophagectomy. It is proven that an impaired liver function has a strong impact on the postoperative wound healing. Therefore, it is important to be able to measure liver function to avoid major complication. So far there are multiple ways to measure liver function, but none of them has been evaluated preoperative to an esophagectomy. To evaluate this further we plan an observational study.
For the study we chose a risk collective for impaired liver function. Only patients with an squamous cell carcinoma of the esophagus or patients with an adenocarcinoma of the gastroesophageal junction and an BMI higher than 30 will be included.
The liver function will be evaluated preoperatively via LiMAx, FibroScan, blood values, LiverMultiScan, CT and MRI. As gold standard diagnostic for liver morphology a liver biopsy will be taken at the beginning of the operation. Subsequently, all different test methods will be compared to each other. The aim is to specify whether there is a correlation between those liver function tests and whether they are able to discriminate between different patient groups according to their liver function. This should be the foundation to a bigger study, where we would like to correlate the preoperative testing with the postoperative outcome of the patients and their complications to be able to establish a preoperative testing routine and to find cut off values to determine operability in case of liver impairment.

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

No

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Description IPD sharing plan:

Data will be collected, evaluated and published by the designated study Team. A preliminary cooperation with sharing of selected datapoints is not planned at the moment

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Organizational Data

  •   DRKS00019201
  •   2019/12/17
  •   [---]*
  •   yes
  •   Approved
  •   19-1448, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   C15.1 -  Malignant neoplasm: Thoracic part of oesophagus
  •   C16.0 -  Malignant neoplasm: Cardia
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Interventions/Observational Groups

  •   Liver function test via LiMAx, FibroScan, blood test, MultiLiverScan, CT, MRI, macroscopy and biopsy
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Characteristics

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

Aim is the comparison of the available non-invasive liver function test with the liver biopsy

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Secondary Outcome

[---]*

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2020/01/06
  •   40
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   100   Years
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Additional Inclusion Criteria

squamous cell carcinoma of the middle or distal esophagus or

adenocarcinoma of the esophagogastric junction Typ I or II with a BMI over 30

neoadjuvant radiochemotherapy or chemotherapy

Initial staging uT2-3 Nx M0

Informed patients consent

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Exclusion Criteria

ASA ≥ IV
FEV1 < 1,5 l
ECOG ≥ 2
Non-resectable primary tumours

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Addresses

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    • Universitätsklinikum Köln
    • Ms.  Dr. med.  Denise  Buchner 
    • Kerpener Str. 62
    • 50924  Köln
    • Germany
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    • Universitätsklinikum Köln
    • Ms.  Dr. med.  Denise  Buchner 
    • Kerpener Str. 62
    • 50924  Köln
    • Germany
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    • Universitätsklinikum Köln
    • Ms.  Dr. med.   Denise  Buchner 
    • Kerpener Str. 62
    • 50924  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Köln
    • Kerpener Str. 62
    • 50924  Köln
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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