Endometrial Adenocarcinoma, Endometrial Cancer, Endometrial Cancer Stage I, Endometrial Cancer Stage II, Endometrial Endometrioid Adenocarcinoma, Endometrial Neoplasms, Hysterectomy, Laparoscopic Hysterectomy, Sentinel Lymph Node
Conditions
Keywords
Endometrial Cancer, Endometrial Adenocarcinoma, Sentinel Lymph Node Biopsy, Laparoscopic Hysterectomy, Adjuvant Therapy, FIGO
Brief summary
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.
Interventions
PROCEDURELaparoscopic total hysterectomy with bilateral salpingo-oophorectomy and sentinel lymph node biopsy
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.
Sponsors
Moscow City Oncology Hospital No. 62
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A single-center prospective open-label single-arm clinical trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in postoperative treatment strategy | Up to 3 weeks after surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adjustments in FIGO staging | Up to 3 weeks after surgery | The rate of change in disease stage based on SLNB results and postoperative histology (percentage). |
| Bilateral SLN detection | At the end of the surgery - 1 day | The rate of bilateral SLN detection (percentage). |
| Details of intraoperative complications of SLN biopsy | At the end of the surgery - 1 day | 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). |
| The rate of intraoperative complications of SLN biopsy | At the end of the surgery - 1 day | Percentage of patients experiencing intraoperative complications associated with SLN mapping and biopsy listed above. |
| Major postoperative morbidity | Up to 30 days after surgery | Major postoperative morbidity following the procedure (percentage). |
| Postoperative mortality | Up to 30 days after surgery | Postoperative mortality following the procedure (percentage). |
| Incidence of lymphedema | Up to 24 months after surgery | The rate of lower extremities lymphedema (percentage). |
| Pelvic recurrence rate | 24 months after surgery | The percentage of patients experiencing pelvic recurrence after surgical treatment. |
| Time to pelvic recurrence | 24 months after surgery | Time from surgical treatment to detected pelvic recurrence in months. |
Countries
Russia
Outcome results
None listed