Lymph Node Mapping Via Flourescent Dye in Colon Cancer

Официальное название

Lymph Node Mapping Via the Flourescent Dye ICG in Colon Cancer Through Preoperative Application

Обзор

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. 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.

Подробное описание

Participants with a diagnosed (andeno)carcinoma of the ascending, transverse, descending and sigmoid colon will be included. Preoperatively the participants will receive an indocyanine green(ICG) injection at four points around the tumour endoscopically. The ICG marking will take place one to five days prior to surgery. In the draining lymph nodes of the specific region the ICG will accumulate and thus visible via fluorescence-camera during the surgery.

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.

Вмешательства

• Процедура ICG-marking endoscopically
  Preoperatively the participants will receive an endoscopic marking at four points around the tumour with the fluorescent dye indocyanine green.

Первичные конечные точки

• Intraoperative ICG-positive lymph nodes in vivo after endoscopic marking of the tumour [Срок оценки: intraoperative assessment]
• Video-analysis of ICG-positive lymph nodes in vivo after endoscopic marking of the tumour [Срок оценки: video-analysis within one week after surgery]
• Number of ICG-positive lymph nodes after endoscopic marking of the tumour [Срок оценки: within one week after surgery]
• Correlation of nodal-positive lymph nodes inside/outside the standard resection area [Срок оценки: within one week after surgery]

Критерии участия

Критерии включения

• histologically diagnosed carcinoma of the ascending, transverse, descending or sigmoid colon.

Критерии исключения

• not wanting to participate
• other carcinoma then adenocarcinoma
• endoscopic marking not possible

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Германия · 1 центр

• University of Hamburg Medical Institutions — Hamburg

Идентификаторы

NCT: NCT04959604 · CCLNM

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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