Trial document



drksid header

  DRKS00016367

Trial Description

start of 1:1-Block title

Title

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

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

ESOMAP Trial

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

http://not available

end of 1:1-Block url
start of 1:1-Block public summary

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.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

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.

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

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

No

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

[---]*

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00016367
  •   2019/01/04
  •   [---]*
  •   yes
  •   Approved
  •   19-1463, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   C15.5 -  Malignant neoplasm: Lower third of oesophagus
end of 1:N-Block indications
start of 1:N-Block interventions

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.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Prognosis
  •   Single (group)
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

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.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

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.

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2019/12/02
  •   20
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

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

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

Patient refuses intervention

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinik und Poliklinik für Allgemein-, Viszeral- und TumorchirurgieUniklinik Köln
    • Mr.  Dr. med  Hans  Fuchs 
    • Kerpener Str. 62
    • 50937  Köln
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Klinik und Poliklinik für Allgemein-, Viszeral- und TumorchirurgieUniklinik Köln
    • Mr.  Dr. med  Hans  Fuchs 
    • Kerpener Str. 62
    • 50937  Köln
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Klinik und Poliklinik für Allgemein-, Viszeral- und TumorchirurgieUniklinik Köln
    • Mr.  Dr. med  Hans  Fuchs 
    • Kerpener Str. 62
    • 50937  Köln
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Intuitive Surgical Deutschland GmbH
    • Ms.  Martha  Bean 
    • Pelmanstrasse 46
    • 45131  Essen
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.