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

Not Applicable

Completed

• Conditions: Endometrial Cancer; Endometrial Neoplasms; Sentinel Lymph Node Biopsy (SLNB)

• Registration Number: NCT05191212
• Lead Sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Brief 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.

Detailed Description

Primary treatment of clinical early-stage endometrial cancer consists of total hysterectomy, bilateral salpingo-oophorectomy, and lymph node assessment for staging. Sentinel lymph node (SLN) biopsy using indocyanine green (ICG) has been recommended in international guidelines as an alternative to systematic lymphadenectomy.

Conventional cervical ICG injection achieves bilateral SLN detection rates of approximately 73-75%. Re-injection may increase detection but prolongs the procedure. To optimize this approach, the investigators developed a modified technique in which ICG injection is continued until real-time lymphatic channels are visualized intraoperatively using the Firefly fluorescence mode of the robotic system.

The trial was designed as a prospective, randomized study comparing the conventional method with the modified technique in patients with clinical early-stage endometrial cancer undergoing robotic surgery. Participants were randomized in a 1:1 ratio to either the conventional cervical ICG injection group or the real-time lymphatic channel-guided ICG injection group. Randomization was performed using a computer-generated random sequence.

Initially, a sample size of 24 participants per group was planned, assuming bilateral detection rates of 75% (conventional) and 99% (modified). During the course of the study, the observed rates were 82.5% and 97.5%, respectively. A revised power analysis indicated the need for 40 participants per group, and the protocol was amended accordingly.

The study was completed with 40 participants in each group. The primary outcome was the rate of bilateral SLN detection. Secondary outcomes included operative parameters and perioperative complications.

Study Timeline

• Study Start: 2021-07-13
• Study First Submitted: 2021-12-29
• Study First Submitted QC: 2021-12-29
• Study First Posted: 2022-01-13
• Status Verified: 2025-09
• Primary Completion: 2025-09-01
• Study Completion: 2025-09-15
• Last Update Submitted: 2025-09-23
• Last Update Posted: 2025-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Bilateral sentinel lymph node detection rate	Intraoperative (during surgery)	Proportion of patients in whom sentinel lymph nodes are successfully identified bilaterally.

Secondary Outcome Measures

Name	Time	Method
Unilateral Sentinel Lymph Node Detection Rate	Intraoperative	Proportion of patients in whom SLNs are detected unilaterally
Overall Sentinel Lymph Node Detection Rate (bilateral + unilateral)	Intraoperative	Proportion of patients with any SLN detected
Operative Time	From skin incision to skin closure	Total surgical duration measured in minutes
Time Required for Bilateral Sentinel Lymph Node Removal	Intraoperative (measured during surgery)	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
Estimated Blood Loss	During surgery	Amount of blood loss measured intraoperatively (mL)
Intraoperative and Postoperative Complications	Up to 30 days after surgery	Any complications observed intraoperatively or within 30 days postoperatively

Trial Locations

Locations (1)

Gökhan Demirayak; Istanbul, Turkey (Türkiye)