An interventional study of indocyanine green in Endometrial Cancer, Endometrial Neoplasms and Sentinel Lymph Node Biopsy (SLNB), sponsored by Bakirkoy Dr. Sadi Konuk Research and Training Hospital. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-09-24.
Sponsored by Bakirkoy Dr. Sadi Konuk Research and Training Hospital · Not applicable, Interventional, and Diagnostic
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.
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.
1,325 studies on the registry are indexed under Endometrial Neoplasms; 447 are open to participants now.
This study's enrollment of 80 is above the median of 70 across 941 interventional studies indexed under Endometrial Neoplasms.
Browse Endometrial Neoplasms studies →Bakirkoy Dr. Sadi Konuk Research and Training Hospital is the lead sponsor of 118 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Cervical indocyanine green injections until real-time visualization of the afferent lymphatic channels bilaterally.
Procedure: indocyanine green
Cervical indocyanine green injections group
Procedure: indocyanine green
Cervical indocyanine green injection for the detection of sentinel lymph node
Bilateral sentinel lymph node detection rate
Proportion of patients in whom sentinel lymph nodes are successfully identified bilaterally.
Time frame: Intraoperative (during surgery)
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
Length of Hospital Stay
Number of days from surgery to hospital discharge
Time frame: From immediately after surgery through hospital discharge (expected average of 2 days)
Need for Blood Transfusion
Proportion of patients requiring intraoperative or postoperative blood product transfusion
Time frame: Perioperative period
Need for ICU Admission
Proportion of patients requiring intensive care unit admission postoperatively
Time frame: From ICU admission through ICU discharge, an average of 1 day
Plan to share: No — Individual participant data will not be shared due to patient privacy concerns and institutional regulations; however, de-identified aggregate data will be available upon reasonable request.
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Bakirkoy Dr. Sadi Konuk Research and Training Hospital