Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2021-05-31
2026-12-30
Brief Summary
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The draining lymph nodes will be visualized using the fluorescent dye indocyanine green.
The aim of the study is to evaluate whether lymph nodes draining the region of the carcinoma are located only inside the lines of standard resection or in some percentages are located outside as well. The visualized nodes draining the region of the carcinoma will be correlated to location, fluorescent yes/no and nodal positive/negative.
The draining lymph nodes will be visualized using the fluorescent dye indocyanine green.
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Detailed Description
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Intraoperatively, the precise locations of all fluorescent nodes will be documented photographically. A standard resection and lymph node dissection will be conducted, potential fluorescent nodes outside the standard resection lines will additionally be resected. The fresh specimen will then be measured, the fluorescent nodes marked and after the pathologic examination the nodes will be correlated to location, fluorescent yes/no and nodal positive/negative.
The aim ist not the visualization of the Sentinel node or the directly draining lymphatic vessel but all the nodes draining the peritumorous region at the point of surgery.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ICG-marked Colon Carcinoma
The participants will receive an endoscopic marking via ICG preoperatively
ICG-marking endoscopically
Preoperatively the participants will receive an endoscopic marking at four points around the tumour with the fluorescent dye indocyanine green.
Interventions
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ICG-marking endoscopically
Preoperatively the participants will receive an endoscopic marking at four points around the tumour with the fluorescent dye indocyanine green.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* other carcinoma then adenocarcinoma
* endoscopic marking not possible
18 Years
100 Years
ALL
No
Sponsors
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Universitätsklinikum Hamburg-Eppendorf
OTHER
Responsible Party
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Principal Investigators
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Daniel Perez, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Dept of General Visceral and Thoracic Surgery
Locations
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University of Hamburg Medical Institutions
Hamburg, , Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CCLNM
Identifier Type: -
Identifier Source: org_study_id
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