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

NCT04972682 | Completed

• 1 other identifier: MCOH62-07-08-21
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Endometrial Cancer; Endometrial Adenocarcinoma; Sentinel Lymph Node Biopsy; Laparoscopic Hysterectomy; Adjuvant Therapy; FIGO

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Adjustments in FIGO staging

  Up to 3 weeks after surgery

• Bilateral SLN detection

  At the end of the surgery - 1 day

• Details of intraoperative complications of SLN biopsy

  At the end of the surgery - 1 day

• The rate of intraoperative complications of SLN biopsy

  At the end of the surgery - 1 day

• Major postoperative morbidity

  Up to 30 days after surgery

Study Arms (1)

Laparoscopic total hysterectomy with bilateral salpingo-oophorectomy and sentinel lymph node biopsy

EXPERIMENTAL

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

Interventions

Laparoscopic total hysterectomy with bilateral salpingo-oophorectomy and sentinel lymph node biopsy PROCEDURE

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.

Laparoscopic total hysterectomy with bilateral salpingo-oophorectomy and sentinel lymph node biopsy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Moscow City Oncology Hospital No. 62: lead

Study Sites (1)

1. Department of Gynecologic Oncology, Moscow City Oncology Hospital No. 62

Istra, Moscow Oblast, 143515, Russia

Location

Related Publications (1)

• Sorokin P, Novozhilov M, Utkin D, Abduragimova Z, Dudina I, Nikiforchin A, Kulikova S. Tailoring postoperative management through sentinel lymph node biopsy in low- and intermediate-risk endometrial cancer - the SENTRY clinical trial. Klin Onkol. 2024;38(2):126-133. doi: 10.48095/ccko2024126.

  PMID: 38697821 RESULT

Related Links

• The SENTRY clinical trial is a prospective open-label single-arm clinical trial aimed to evaluate the impact of SLN biopsy on the postoperative decision-making process in patients with presumed low- and intermediate-risk endometrial cancer.

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Sentinel Lymph Node Biopsy

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Lymph Node Excision; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: A single-center prospective open-label single-arm clinical trial

Study Record Dates

• First Submitted: July 12, 2021
• First Posted: July 22, 2021
• Study Start: July 1, 2021
• Primary Completion: August 15, 2023
• Study Completion: April 15, 2024
• Last Updated: May 7, 2024

Record last verified: 2024-05

Locations

RU (1)