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

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

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pavel Sorokin, MD; Phone Number: +79111352789; Email: sor-pavel@ya.ru
• Study Contact Backup: Name: Svetlana Kulikova, MD; Phone Number: +79036266741; Email: s_s72@mail.ru

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

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

How is the study designed?

Design Details

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

Number of Arms

1

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

Collaborators and Investigators

• Sponsor: Moscow City Oncology Hospital No. 62

Publications and helpful links

Helpful Links

• Related Info

Study record dates

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): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 19, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Endometrial Cancer; Adjuvant Therapy; Sentinel Lymph Node Biopsy; Endometrial Adenocarcinoma; Laparoscopic Hysterectomy; FIGO
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Diseases; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Ovarian Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Adenocarcinoma; Endometrial Neoplasms; Carcinoma, Endometrioid
• 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