Clinical trial NCT04959604: Lymph Node Mapping Via Flourescent Dye in Colon Cancer
Official title: Lymph Node Mapping Via the Flourescent Dye ICG in Colon Cancer Through Preoperative Application
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colon Carcinoma
Lymph Node Metastases
Keywords: indocyanine green
lymphatic mapping
fluorescence
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2021-07-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Intervention group. Participants will receive a state of the art surgical procedure with additional lymph node mapping
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Intraoperative ICG-positive lymph nodes in vivo after endoscopic marking of the tumour
timeFrame: intraoperative assessment
measure: Video-analysis of ICG-positive lymph nodes in vivo after endoscopic marking of the tumour
timeFrame: video-analysis within one week after surgery
measure: Number of ICG-positive lymph nodes after endoscopic marking of the tumour
timeFrame: within one week after surgery
measure: Correlation of nodal-positive lymph nodes inside/outside the standard resection area
timeFrame: within one week after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: University of Hamburg Medical Institutions
Study officials:
affiliation: Dept of General Visceral and Thoracic Surgery
name: Daniel Perez, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: