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

Moscow City Oncology Hospital No. 62

Status: Completed

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

Treatments: Procedure: Laparoscopic total hysterectomy with bilateral salpingo-oophorectomy and sentinel lymph node biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT04972682

MCOH62-07-08-21

Details and patient eligibility

About

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.

Enrollment: 102 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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102 participants in 1 patient group

Laparoscopic total hysterectomy with bilateral salpingo-oophorectomy and sentinel lymph node biopsy

Experimental group

Description:

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).

Treatment:

Procedure: Laparoscopic total hysterectomy with bilateral salpingo-oophorectomy and sentinel lymph node biopsy