Trial document




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  DRKS00016367

Trial Description

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Title

Mapping the Lymphatic Drainage Pattern of Esophageal Cancer with Near-Infrared Fluorescent Imaging

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Trial Acronym

ESOMAP Trial

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URL of the Trial

http://not available

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Brief Summary in Lay Language

Nodal status is one of the most important long-term prognostic factors for esophageal cancer. The lymphatic drainage pattern of cardia cancer, which is a subtype of esophageal cancer, is incompletely understood and there is still debate on different surgical ways. Second, some early cancers that can technically be cut out endoscopically (during a gastroscopy for example) and then may not need a surgery where the lymph nodes are cut out. Those patients may benefit from a surgical, minimal invasive screeing using near-infrared (NIR) light fluorescent imaging to identify the patient specific lymphatic drainage.The aim of this study is to evaluate the ability of near-infrared (NIR) light fluorescentimaging to identify the lymphatic drainage pattern of esophageal cancer.

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Brief Summary in Scientific Language

Nodal status is one of the most important long-term prognostic factors for esophageal cancer. The lymphatic drainage pattern of cardia cancer is incompletely understood and there is still debate how radical the abdominal and thoracic lymphadenectomy needs to be. Second, some early cancers that can technically be resected endoscopically may not need a formal lymphadenectomy and may therefore benefit from a screening laparoscopy/thoracoscopy using near-infrared (NIR) light fluorescent imaging to identify the patient specific lymphatic drainage.
The aim of this study is to evaluate the ability of near-infrared (NIR) light fluorescent imaging to identify the lymphatic drainage pattern of esophageal cancer.

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Organizational Data

  •   DRKS00016367
  •   2019/01/04
  •   [---]*
  •   yes
  •   [---]*
  •   [---]*
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Secondary IDs

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

  •   C15.5 -  Malignant neoplasm: Lower third of oesophagus
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Interventions/Observational Groups

  •   Patients with distal esophageal cancer or esophagogastric junction cancer (cancer of the cardia) scheduled for esophagectomy will be enrolled in this study. Before surgery, an endoscopy will performed with submucosal injection of 2 cc of indocyanine green (ICG) around the tumor. Real-time NIR (Near-infrared spectroscopy) images from the surgical
    field will be obtained for each patient to visualize the lymphatic ICG drainage. A correlation will be performed with histopathological work-up of these lymph nodes to prove feasibility of the technique.
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Prognosis
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Patients will undergo laparoscopic mobilization of the stomach and abdominal lymphadenectomy, followed by transthoracic thoracoscopic or open esophagectomy and thoracic lymphadenectomy using fluorescence imaging as a guide for complete
lymph node dissection and to preserve the lymphatic channels. Affected nodes as detected by fluorescence imaging will be marked and dissected separately for later histopathological workup. Primary endpoint will be therefore the visualization of lymphatic channels along first and second tier nodes during the surgery.

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Secondary Outcome

Pattern of lymph nodes metastatic spread of advanced esophageal Cancer along lymphatic channels (proximal to distal from the Tumor or has direct communication with distal nodes or multidirectional resulting skip metastasis). Visualization during surgery.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2019/06/01
  •   20
  •   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

Patients with clinically advanced stage adenocarcinoma of the esophagus (T2-T4, N0-N3) undergoing surgical resection

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Exclusion Criteria

Patient refuses intervention

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Addresses

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    • Klinik und Poliklinik für Allgemein-, Viszeral- und TumorchirurgieUniklinik Köln
    • Mr.  Dr. med  Hans  Fuchs 
    • Kerpener Str. 62
    • 50937  Köln
    • Germany
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    • Klinik und Poliklinik für Allgemein-, Viszeral- und TumorchirurgieUniklinik Köln
    • Mr.  Dr. med  Hans  Fuchs 
    • Kerpener Str. 62
    • 50937  Köln
    • Germany
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    • Klinik und Poliklinik für Allgemein-, Viszeral- und TumorchirurgieUniklinik Köln
    • Mr.  Dr. med  Hans  Fuchs 
    • Kerpener Str. 62
    • 50937  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Intuitive Surgical Deutschland GmbH
    • Ms.  Martha  Bean 
    • Pelmanstrasse 46
    • 45131  Essen
    • 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.