Feasibility, sensitivity and detection rate of Sentinel Lymph Node Mapping Using hand-held NIR Fluorescence camera with ICG in Early Stage Endometrial Cancer: A pilot study from a tertiary cancer care Center.

Significant advances in the surgical management of endometrial cancer are the safe

adoption of minimally invasive surgery and the use of sentinel lymph node(SLN)

mapping through fluorescence-guided minimally invasive surgery. Several trials

comparing the accuracy of SLN, lymphadenectomy or SNL plus lymphadenectomy have

confirmed that SLN is not inferior in identifying nodal disease.Blue dye,

radiotracer 99mTc and Indocyanine green dye (ICG) are commonly explored in

endometrial cancer, and now, recently, sentinel node mapping using indocyanine green

is much assuring.Blue dye is associated with allergic reactions, and radiolabelled tracer is related to many

logistic challenges and costs despite better detection rates. ICG dye is a fluorescent dye

approved by the FDA. It can be lighted with near-infrared fluorescent light and is

extensively used in intra-operative imaging for better anatomic and functional

information. Our institute has recently acquired the IRILIC NIR handheld camera, which

can be used intra-operatively in open surgery.

Study Method

Prospective, open-labeled, non-randomized exploratory intervention trial

The organisation of work elements

Written informed consent will be obtained from patients who fulfil the inclusion criteria

and are willing to participate in the study.

Intraoperative assessment

After anaesthesia, a laparotomy incision will be made midline vertical. After entry into

the peritoneal cavity, peritoneal wash cytology will be taken. A thorough assessment of

abdominal activity will be conducted to rule out any significant lymph nodes or gross

extrauterine disease. SLN mapping will be started after ruling out extrauterine disease.

SLN Mapping

1. Intra-cervical injection of ICG at 3 and 9 o’clock positions at concentrations of

1.25mg/ml, submucosally(2-3mm) and deep 1 cm into the stroma, one ml per

injection site. One vial of AUROGREEN ( ICG powder 25mg) will be constituted

with 20 ml of sterile water to obtain the concentration.

2. Post injection, room lights are switched off to obtain a dark operating room and

almost immediately, the pelvic spaces will be opened to do sentinel mapping

using the hand-held NIR camera.

3. The sentinel nodes are those identified in proximity to the uterus lighted up in

fluorescent green colour on the NIR camera.

4. Only lymphatic channels draining to a node are seen, and if the node is not

lightened up, it can also be considered a sentinel node.

5. Detected nodes will be sent for a staging procedure in the final histopathological

examination with ultra staging.

6. As this is planned as a pilot study, after SLN mapping, irrespective of the dye

uptake, routine lymphadenectomy as indicated for the histology, grade, and stage

will be done, including pelvic and para-aortic lymphadenectomy.

Schedule

After the approval, 20 consecutive cases of carcinoma endometrium fulfilling the

selection criteria and undergoing staging laparotomy will be recruited for the present

study.