[SENTRY] Tailoring Postoperative Management Through Sentinel Lymph Node Biopsy in Low- and Intermediate-Risk Endometrial Cancer

Study Overview
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Brief Summary
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While total hysterectomy without lymph node staging is standard for low- and intermediate-risk endometrial cancer, certain histopathologic factors can necessitate additional interventions. Our study assesses the influence of sentinel lymph node (SLN) biopsy on postoperative decision-making.

Official Title
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Tailoring Postoperative Management Through Sentinel Lymph Node Biopsy in Low- and Intermediate-Risk Endometrial Cancer: a Prospective Open-label Single-arm Clinical Trial

Conditions
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Sentinel Lymph Node, Endometrial Cancer, Endometrial Neoplasms, Endometrial Adenocarcinoma, Endometrial Cancer Stage I, Endometrial Cancer Stage II, Endometrial Endometrioid Adenocarcinoma, Hysterectomy, Laparoscopic Hysterectomy

Intervention / Treatment
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* Procedure: Laparoscopic total hysterectomy with bilateral salpingo-oophorectomy and sentinel lymph node biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years Histologically verified low-grade endometrioid adenocarcinoma of the endometrium (G1-G2) FIGO stage IA FIGO stage IB and II when LND is contraindicated No contraindications for surgery Signed informed consent Exclusion Criteria: • Age <18 years Presence of tumor spread outside the corpus uteri Absence of tumor invasion into the myometrium High-grade tumor (G3) Bokhman type 2 tumor (e.g., clear cell adenocarcinoma, serous adenocarcinoma, carcinosarcoma, endometrial stromal sarcoma) Preoperative treatment of endometrial cancer including radiotherapy, systemic chemotherapy, or hormone therapy Prior pelvic or retroperitoneal LND History of surgeries on the uterus and uterine appendages, with exceptions such as cesarean section, tubectomy, oophorectomy, ovarian resection, ovarian biopsy, and ovarian cauterization Allergy to iodine-containing drugs Contraindications to surgical treatment Lack of signed informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: A single-center prospective open-label single-arm clinical trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laparoscopic total hysterectomy with bilateral salpingo-oophorectomy and sentinel lymph node biopsy<br>This arm includes patients with endometrioid adenocarcinoma of the endometrium of low- and intermediate-risk who will undergo a laparoscopic total hysterectomy and bilateral salpingo-oophorectomy with sentinel lymph node biopsy (SLNB) performed with near-infrared-guided surgery using indocyanine green (ICG). | Procedure: Laparoscopic total hysterectomy with bilateral salpingo-oophorectomy and sentinel lymph node biopsy<br>* Laparoscopic total hysterectomy, bilateral salpingo-oophorectomy (BSO), and sentinel lymph node (SLN) biopsy are executed by 1 of 5 experienced gynecologic oncologists. SLN mapping utilizes indocyanine green (ICG) at a standard concentration of 2.5 mg/mL - 1 mL is injected into the cervix at the 3 and 9 o'clock positions (total dose - 5 mg) to a depth of 5-10 mm, initiated right after general anesthesia induction. Diagnostic laparoscopy employs the Image 1S equipment (KARL STORZ©, Tuttlingen, Germany). Upon examination, fluorescence in the near-infrared spectrum is observed. Successful mapping is indicated by identifying a lymphatic vessel with at least one LN. Detected SLNs are then extracted, and the total hysterectomy with BSO is completed. SLN frozen section remains at the surgeon's discretion. If metastasis surfaces in the SLN either during the frozen section or routine assessment, the option for systematic LN dissection in a subsequent procedure exists although not mandatory.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in postoperative treatment strategy | The rate of change in postoperative treatment based on the SLNB results and postoperative histology (percentage). A change in postoperative treatment strategy is defined as any difference between treatment plans set by the tumor board before and after receiving the SLN biopsy information. | Up to 3 weeks after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adjustments in FIGO staging | The rate of change in disease stage based on SLNB results and postoperative histology (percentage). | Up to 3 weeks after surgery | 
| Bilateral SLN detection | The rate of bilateral SLN detection (percentage). | At the end of the surgery - 1 day | 
| Details of intraoperative complications of SLN biopsy | The actual list of intraoperative complications associated with SLN mapping and biopsy. They include but are not limited to an intraoperative bleeding, small and large bowel injury, ureter and bladder injury, nerve injury, and allergic reaction to indocyanine green (ICG). | At the end of the surgery - 1 day | 
| The rate of intraoperative complications of SLN biopsy | Percentage of patients experiencing intraoperative complications associated with SLN mapping and biopsy listed above. | At the end of the surgery - 1 day | 
| Major postoperative morbidity | Major postoperative morbidity following the procedure (percentage). | Up to 30 days after surgery | 
| Postoperative mortality | Postoperative mortality following the procedure (percentage). | Up to 30 days after surgery | 
| Incidence of lymphedema | The rate of lower extremities lymphedema (percentage). | Up to 24 months after surgery | 
| Pelvic recurrence rate | The percentage of patients experiencing pelvic recurrence after surgical treatment. | 24 months after surgery | 
| Time to pelvic recurrence | Time from surgical treatment to detected pelvic recurrence in months. | 24 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endometrial Cancer, Endometrial Adenocarcinoma, Sentinel Lymph Node Biopsy, Laparoscopic Hysterectomy, Adjuvant Therapy, FIGO