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NCT Number: NCT05191212

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

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.

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Key information

Conditions

Endometrial Cancer Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Sentinel Lymph Node Biopsy (SLNB) Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Gökhan Demirayak

Istanbul, 34147, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Indocyanine Green

Procedure

Cervical indocyanine green injection for the detection of sentinel lymph node

Primary outcomes

  1. Bilateral sentinel lymph node detection rate

    Time frame: Intraoperative (during surgery)

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

Secondary outcomes

  1. Unilateral Sentinel Lymph Node Detection Rate

    Time frame: Intraoperative

    Proportion of patients in whom SLNs are detected unilaterally

  2. Overall Sentinel Lymph Node Detection Rate (bilateral + unilateral)

    Time frame: Intraoperative

    Proportion of patients with any SLN detected

  3. Operative Time

    Time frame: From skin incision to skin closure

    Total surgical duration measured in minutes

  4. Time Required for Bilateral Sentinel Lymph Node Removal

    Time frame: 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

  5. Estimated Blood Loss

    Time frame: During surgery

    Amount of blood loss measured intraoperatively (mL)

  6. Intraoperative and Postoperative Complications

    Time frame: Up to 30 days after surgery

    Any complications observed intraoperatively or within 30 days postoperatively

Other outcomes

  1. Length of Hospital Stay

    Time frame: From immediately after surgery through hospital discharge (expected average of 2 days)

    Number of days from surgery to hospital discharge

  2. Need for Blood Transfusion

    Time frame: Perioperative period

    Proportion of patients requiring intraoperative or postoperative blood product transfusion

  3. Need for ICU Admission

    Time frame: From ICU admission through ICU discharge, an average of 1 day

    Proportion of patients requiring intensive care unit admission postoperatively

Sponsors and collaborators

Lead sponsor

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jan 13, 2022
Registry last updated
Sep 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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