Endometrial Cancer, Endometrial Neoplasms, Sentinel Lymph Node Biopsy (SLNB)
Conditions
Keywords
Endometrial cancer, Sentinel lymph node, İndocyanine green, Lymphatic channel, Lymphatic Channel Visualization, Uterine cancer, Da Vinci Surgical System, Robotic Surgery, Real-time Visualization, Fluorescence Imaging, Near-Infrared Fluorescence, Gynecologic Oncology, Endometrial neoplasms
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.
Interventions
PROCEDUREindocyanine green
Cervical indocyanine green injection for the detection of sentinel lymph node
Sponsors
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
Not applicable. This is an open-label surgical trial; no parties were masked.
Intervention model description
A prospective, randomized, parallel-group study in which patients with clinical early-stage endometrial cancer are assigned to either conventional cervical indocyanine green (ICG) injection or real-time lymphatic channel-guided ICG injection for sentinel lymph node mapping. Each participant undergoes only one technique according to randomization.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bilateral sentinel lymph node detection rate | Intraoperative (during surgery) | Proportion of patients in whom sentinel lymph nodes are successfully identified bilaterally. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Need for ICU Admission | From ICU admission through ICU discharge, an average of 1 day | Proportion of patients requiring intensive care unit admission postoperatively |
| Length of Hospital Stay | From immediately after surgery through hospital discharge (expected average of 2 days) | Number of days from surgery to hospital discharge |
| Need for Blood Transfusion | Perioperative period | Proportion of patients requiring intraoperative or postoperative blood product transfusion |
Countries
Turkey (Türkiye)
Outcome results
None listed