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Real-time Lymphatic Channel Visualization Improves Bilateral Sentinel Lymph Node Detection in Endometrial Cancer

NCT05191212CompletedNAINTERVENTIONAL

Summary

Endometrial cancer is the most common malignancy of the female genital tract. Standard treatment for early-stage disease includes hysterectomy, bilateral salpingo-oophorectomy, and lymph node assessment. Sentinel lymph node (SLN) mapping with indocyanine green (ICG) has become widely used as an alternative to systematic lymphadenectomy due to lower morbidity and high detection rates. This randomized clinical trial was designed to compare conventional cervical ICG injection with a modified technique, in which injection is continued until real-time lymphatic channels are visualized intraoperatively, for bilateral SLN detection in patients with clinical early-stage endometrial cancer undergoing robotic surgery.

Key Facts

Lead Sponsor

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Enrollment

Start Date

2021-07-13

Completion Date

2025-09-01

Study Type

INTERVENTIONAL

Official Title

Real-time Lymphatic Channel Visualization Compared With Conventional Cervical Indocyanine Green Injection for Sentinel Lymph Node Mapping in Early-stage Endometrial Cancer

Interventions

indocyanine green

Conditions

Endometrial CancerEndometrial NeoplasmsSentinel Lymph Node Biopsy (SLNB)

Eligibility

Age Range

18 Years – 80 Years

Sex

FEMALE

Inclusion Criteria: Patients with clinical stage 1-2 endometrial cancer ASA 1-3 patients. Ability to provide written informed consent

Exclusion Criteria: Patients with clinical stage 3-4 endometrial cancer Patients who are not suitable for robotic surgery due to their comorbidities (such as glaucoma, COPD, asthma) ASA 4-5 patients. Patients unable or unwilling to provide informed consent

Outcome Measures

Primary Outcomes

Bilateral sentinel lymph node detection rate

Proportion of patients in whom sentinel lymph nodes are successfully identified bilaterally.

Time frame: Intraoperative (during surgery)

Secondary Outcomes

Unilateral Sentinel Lymph Node Detection Rate

Proportion of patients in whom SLNs are detected unilaterally

Time frame: Intraoperative

Overall Sentinel Lymph Node Detection Rate (bilateral + unilateral)

Proportion of patients with any SLN detected

Time frame: Intraoperative

Operative Time

Total surgical duration measured in minutes

Time frame: From skin incision to skin closure

Time Required for Bilateral Sentinel Lymph Node Removal

The duration in minutes from the first cervical indocyanine green (ICG) injection to the successful removal of bilateral sentinel lymph nodes. This measure evaluates the efficiency of the mapping technique

Time frame: Intraoperative (measured during surgery)

Estimated Blood Loss

Amount of blood loss measured intraoperatively (mL)

Time frame: During surgery

Intraoperative and Postoperative Complications

Any complications observed intraoperatively or within 30 days postoperatively

Time frame: Up to 30 days after surgery

Locations

Gökhan Demirayak, Istanbul, Turkey (Türkiye)

Linked Diseases

Endometrial Neoplasms

Endometrial Neoplasms — a type of gynecological cancer.

Linked Papers

2021-04-24

Cervical re-injection of indocyanine green to improve sentinel lymph node detection in endometrial cancer

To evaluate the role of cervical re-injection of indocyanine green (ICG) to increase the detection rate of sentinel lymph node (SLN) in patients with endometrial cancer (EC) who underwent robotic-assisted surgical staging. We retrospectively identified consecutive EC patients undergoing robotic-assisted staging with SLN biopsy at our Institution between June 2016 and April 2020. Patients were excluded if they had open abdominal surgical approach, neoadjuvant chemotherapy, and advanced stage [International Federation of Gynecology and Obstetrics (FIGO) stage III-IV] at diagnosis. According to our SLN protocol, in case of either unilateral or no SLN detection, we performed an ipsilateral or bilateral cervical re-injection of ICG. In total, 251 patients meeting inclusion criteria were included in the analysis. At first injection, bilateral detection was achieved in 184 (73.3%), unilateral detection in 57 (22.7%), and no detection in 10 (4.0%) patients. Cervical re-injection was performed in 51 of 67 patients with failed bilateral mapping. After cervical re-injection, bilateral detection rate increased to 94.5% (222/235), while unilateral and no detection were 5.1% (12/235) and 0.4% (1/235), respectively. Our results suggest that cervical re-injection of ICG, in case of failed bilateral mapping of SLN, brings about a significant improvement in SLN detection rates, therefore reducing the number of side-specific required lymphadenectomies.