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

Not Applicable

Completed

• Conditions: Endometrial Neoplasms; Sentinel Lymph Node; Laparoscopic Hysterectomy; Endometrial Cancer; Endometrial Cancer Stage I; Endometrial Adenocarcinoma; Endometrial Cancer Stage II; Endometrial Endometrioid Adenocarcinoma; Hysterectomy
• Interventions: Procedure: Laparoscopic total hysterectomy with bilateral salpingo-oophorectomy and sentinel lymph node biopsy

• Registration Number: NCT04972682
• Lead Sponsor: Moscow City Oncology Hospital No. 62

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-01
• Study First Submitted: 2021-07-12
• Study First Submitted QC: 2021-07-21
• Study First Posted: 2021-07-22
• Primary Completion: 2023-08-15
• Study Completion: 2024-04-15
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-03
• Last Update Posted: 2024-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 102

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Laparoscopic total hysterectomy with bilateral salpingo-oophorectomy and sentinel lymph node biopsy	Laparoscopic total hysterectomy with bilateral salpingo-oophorectomy and sentinel lymph node biopsy	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).

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).
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).
Bilateral SLN detection	At the end of the surgery - 1 day	The rate of bilateral SLN detection (percentage).
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.
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).
Time to pelvic recurrence	24 months after surgery	Time from surgical treatment to detected pelvic recurrence in months.
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.

Trial Locations

Locations (1)

1. Department of Gynecologic Oncology, Moscow City Oncology Hospital No. 62; 🇷🇺 Istra, Moskovskaya Oblast, Russian Federation