Trial document




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  DRKS00015030

Trial Description

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Title

Indocyanine green fluorescence angiography of adrenal glands

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Trial Acronym

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The aim of the study is to visualize the adrenal glands during laparoscopic adrenalectomy by using indocyanine green fluorescent staining. This may help to facilitate the identification of the left sided glands and to evaluate the vascularity of remnant tissue in case of partial resection.

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Brief Summary in Scientific Language

Aim of the study is to improve the identification of the left adrenal Gland during laparoscopic adrenalectomy by using the fluorophore indocyanine green. In right lateral position, after mobilization ofspleen and pancreatic tail 5-10mg of indocyanine green and given i.v. as a bolus. We expect a strong fluorescence of the adrenal Gland distinguishing it from the surrounding adipose tissue.
In case of partial adrenalectomy, left or right, we will evaluate the vascularity of the remnant and correlate the results with the remaining hormonal function.

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Organizational Data

  •   DRKS00015030
  •   2018/07/02
  •   [---]*
  •   yes
  •   Approved
  •   17-119 (Amendment), Ethik-Kommission der Medizinischen Fakultät der Ludwig-Maximilians-Universität München
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Secondary IDs

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Health Condition or Problem studied

  •   D35.0 -  Benign neoplasm: Adrenal gland
  •   E26.0 -  Primary hyperaldosteronism
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Interventions/Observational Groups

  •   Indocyanine green 5mg i.v. intraoperatively during laparoscopic adrenalectomy to identify adrenal tissue
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Characteristics

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

Evaluation of the vascularization of adrenal remnant following partial adrenalectomy

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Secondary Outcome

Early identification of the left adrenal gland

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2018/08/01
  •   30
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

All patients who undergo laparoscopic adrenalectomy and give their consent.

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Exclusion Criteria

Patients who are not able to give their consent and patients under the age of 18 years.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Chirurgische Klinik 2
    • Mr.  Professor  Klaus  Hallfeldt 
    • Nussbaumstrasse 20
    • 80336  München
    • Germany
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    • Chirurgische Klinik 2
    • Mr.  Professor  Klaus  Hallfeldt 
    • Nussbaumstrasse 20
    • 80336  München
    • Germany
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  • start of 1:1-Block address public-contact
    • Chirurgische Klinik 2
    • Mr.  Professor  Klaus  Hallfeldt 
    • Nussbaumstrasse 20
    • 80336  München
    • Germany
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Sources of Monetary or Material Support

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    • Chirurgische Klinik 2
    • Mr.  Professor  Klaus  Hallfeldt 
    • Nussbaumstrasse 20
    • 80336  München
    • Germany
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Status

  •   Recruiting planned
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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.