[SENTRY] Sentinel Lymph Node Biopsy Predictive Value in Endometrial Cancer of Low and Intermediate Risk

Sponsor

Moscow City Oncology Hospital No. 62 (Other)

Overall Status

Recruiting

CT.gov ID

NCT04972682

Collaborator

(none)

100

Enrollment

Location

Arm

Anticipated Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Lymphadenectomy performed for endometrial cancer influences the decision on adjuvant therapy. The aim of this study is to evaluate the rate of change in postoperative treatment based on the result of sentinel lymph node biopsy (SLNB).

Condition or Disease	Intervention/Treatment	Phase
Endometrial Cancer Endometrial Neoplasms Endometrial Adenocarcinoma Endometrial Cancer Stage I Endometrial Cancer Stage II Endometrial Endometrioid Adenocarcinoma Sentinel Lymph Node Hysterectomy Laparoscopic Hysterectomy	Procedure: Laparoscopic hysterectomy with sentinel lymph node biopsy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

A single-center prospective descriptive cohort study without a control group.A single-center prospective descriptive cohort study without a control group.

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Sentinel Lymph Node Biopsy Predictive Value in Endometrial Cancer of Low and Intermediate Risk: a Single-center Prospective Descriptive Cohort Study

Actual Study Start Date :

Jul 1, 2021

Anticipated Primary Completion Date :

Jul 1, 2022

Anticipated Study Completion Date :

Jul 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Laparoscopic hysterectomy with sentinel lymph node biopsy This arm includes patients with endometrial adenocarcinoma of low and intermediate risk who will undergo a laparoscopic hysterectomy and sentinel lymph node biopsy (SLNB) performed with near-infrared-guided surgery using indocyanine green (ICG)	Procedure: Laparoscopic hysterectomy with sentinel lymph node biopsy Patients will undergo a laparoscopic hysterectomy and sentinel lymph node (SLN) biopsy performed with near-infrared-guided surgery using indocyanine green (ICG). The standard dilution of the drug is 2.5 mg/mL. One milliliter of the diluted drug will be injected into the cervix at 3 and 9 o'clock (total dose - 5 mg) to a depth of 5-10 mm immediately after the onset of anesthesia. Then diagnostic laparoscopy and revision of the abdomen and pelvis will be performed and Image 1S equipment (KARL STORZ©, Tuttlingen, Germany) will be used for this procedure. After revision, fluorescence in the near-infrared spectrum will be determined. Mapping is considered successful when the lymphatic ducts with at least one lymph node are identified. Then the detected SLN will be harvested and total hysterectomy will be performed. Urgent histological examination of the SLN is optional but can be performed at the discretion of the surgeon. If metastasis is detected in the SLN, lymphadenectomy is allowed.

Arm

Intervention/Treatment

Experimental: Laparoscopic hysterectomy with sentinel lymph node biopsy

This arm includes patients with endometrial adenocarcinoma of low and intermediate risk who will undergo a laparoscopic hysterectomy and sentinel lymph node biopsy (SLNB) performed with near-infrared-guided surgery using indocyanine green (ICG)

Procedure: Laparoscopic hysterectomy with sentinel lymph node biopsy

Patients will undergo a laparoscopic hysterectomy and sentinel lymph node (SLN) biopsy performed with near-infrared-guided surgery using indocyanine green (ICG). The standard dilution of the drug is 2.5 mg/mL. One milliliter of the diluted drug will be injected into the cervix at 3 and 9 o'clock (total dose - 5 mg) to a depth of 5-10 mm immediately after the onset of anesthesia. Then diagnostic laparoscopy and revision of the abdomen and pelvis will be performed and Image 1S equipment (KARL STORZ©, Tuttlingen, Germany) will be used for this procedure. After revision, fluorescence in the near-infrared spectrum will be determined. Mapping is considered successful when the lymphatic ducts with at least one lymph node are identified. Then the detected SLN will be harvested and total hysterectomy will be performed. Urgent histological examination of the SLN is optional but can be performed at the discretion of the surgeon. If metastasis is detected in the SLN, lymphadenectomy is allowed.

Outcome Measures

Primary Outcome Measures

Change in postoperative treatment [Up to 2 weeks]
The rate of change in postoperative treatment based on the SLNB results and postoperative histology.

Secondary Outcome Measures

Change in disease stage [Up to 2 weeks]
The rate of change in disease stage based on SLNB results and postoperative histology
Bilateral SLN detection [At the end of the surgery - 1 day]
The rate of bilateral SLN detection
Intraoperative complications [At the end of the surgery - 1 day]
The rate and details of intraoperative complications
Postoperative morbidity [Up to 15 days]
Early postoperative morbidity
Postoperative mortality [Up to 15 days]
Early postoperative mortality
Lymphatic edema [12 months after surgery]
The rate of lymphatic edema
Local recurrence [12 months after surgery]
Time to recurrence in the pelvis

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Age ≥18
Histologically verified low-grade endometrial adenocarcinoma of the endometrium (G1-G2)
Stage IA (FIGO 2009) according to MRI (CT, ultrasound)
Stage IB and II (FIGO 2009) when lymphadenectomy is contraindicated
No contraindications for surgery
Signed informed consent

Exclusion Criteria:

Age <18
Signs of tumor spread outside the corpus uteri
No signs of tumor invasion into the myometrium
High-grade tumor (G3)
Bokhman type 2 tumor (serous adenocarcinoma, clear cell adenocarcinoma, carcinosarcoma, endometrial stromal sarcoma, etc.)
Preoperative treatment of endometrial cancer (radiation therapy, chemotherapy or hormone therapy)
Prior pelvic or retroperitoneal lymphadenectomy
Prior surgery on the uterus and uterine appendages (except for cesarean section, tubectomy, ovariectomy, ovarian resection, ovarian biopsy, ovarian cauterization)
Surgical treatment is contraindicated
Allergy to iodine-containing drugs
No signed informed consent