MedTrace Logo

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

NCT04972682 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2024-05-07

No results posted yet for this study

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.

Conditions

  • Endometrial Cancer
  • Endometrial Neoplasms
  • Endometrial Adenocarcinoma
  • Endometrial Cancer Stage I
  • Endometrial Cancer Stage II
  • Endometrial Endometrioid Adenocarcinoma
  • Sentinel Lymph Node
  • Hysterectomy
  • Laparoscopic Hysterectomy

Interventions

PROCEDURE

Laparoscopic 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 & Collaborators

  • Moscow City Oncology Hospital No. 62

    lead OTHER_GOV

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-01
Primary Completion
2023-08-15
Completion
2024-04-15

Countries

  • Russia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04972682 on ClinicalTrials.gov