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

May 3, 2024 updated by: Moscow City Oncology Hospital No. 62

Tailoring Postoperative Management Through Sentinel Lymph Node Biopsy in Low- and Intermediate-Risk Endometrial Cancer: a Prospective Open-label Single-arm Clinical Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

102

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
    • Moskovskaya Oblast
      • Istra, Moskovskaya Oblast, Russian Federation, 143515
        • 1. Department of Gynecologic Oncology, Moscow City Oncology Hospital No. 62

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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).
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in postoperative treatment strategy
Time Frame: 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.
Up to 3 weeks after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adjustments in FIGO staging
Time Frame: Up to 3 weeks after surgery
The rate of change in disease stage based on SLNB results and postoperative histology (percentage).
Up to 3 weeks after surgery
Bilateral SLN detection
Time Frame: At the end of the surgery - 1 day
The rate of bilateral SLN detection (percentage).
At the end of the surgery - 1 day
Details of intraoperative complications of SLN biopsy
Time Frame: 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).
At the end of the surgery - 1 day
The rate of intraoperative complications of SLN biopsy
Time Frame: At the end of the surgery - 1 day
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
Time Frame: Up to 30 days after surgery
Major postoperative morbidity following the procedure (percentage).
Up to 30 days after surgery
Postoperative mortality
Time Frame: Up to 30 days after surgery
Postoperative mortality following the procedure (percentage).
Up to 30 days after surgery
Incidence of lymphedema
Time Frame: Up to 24 months after surgery
The rate of lower extremities lymphedema (percentage).
Up to 24 months after surgery
Pelvic recurrence rate
Time Frame: 24 months after surgery
The percentage of patients experiencing pelvic recurrence after surgical treatment.
24 months after surgery
Time to pelvic recurrence
Time Frame: 24 months after surgery
Time from surgical treatment to detected pelvic recurrence in months.
24 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Moscow City Oncology Hospital No. 62

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2021

Primary Completion (Actual)

August 15, 2023

Study Completion (Actual)

April 15, 2024

Study Registration Dates

First Submitted

July 12, 2021

First Submitted That Met QC Criteria

July 21, 2021

First Posted (Actual)

July 22, 2021

Study Record Updates

Last Update Posted (Actual)

May 7, 2024

Last Update Submitted That Met QC Criteria

May 3, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCOH62-07-08-21

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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