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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laparoscopic total hysterectomy with bilateral salpingo-oophorectomy and sentinel lymph node biopsy | Experimental | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic total hysterectomy with bilateral salpingo-oophorectomy and sentinel lymph node biopsy | Procedure | 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. |
| 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 |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1. Department of Gynecologic Oncology, Moscow City Oncology Hospital No. 62 | Istra | Moscow Oblast | 143515 | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38697821 | Result | Sorokin P, Novozhilov M, Utkin D, Abduragimova Z, Dudina I, Nikiforchin A, Kulikova S. Tailoring postoperative management through sentinel lymph node biopsy in low- and intermediate-risk endometrial cancer - the SENTRY clinical trial. Klin Onkol. 2024;38(2):126-133. doi: 10.48095/ccko2024126. |
| Label | URL |
|---|---|
| The SENTRY clinical trial is a prospective open-label single-arm clinical trial aimed to evaluate the impact of SLN biopsy on the postoperative decision-making process in patients with presumed low- and intermediate-risk endometrial cancer. | View source |
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A single-center prospective open-label single-arm clinical trial
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| 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 |
| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| D021701 | Sentinel Lymph Node Biopsy |
| ID | Term |
|---|---|
| D001706 | Biopsy |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D008197 | Lymph Node Excision |
| D008919 | Investigative Techniques |
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