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

NCT ID: NCT04972682

Last Updated: 2024-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-01
• Study Completion Date: 2024-04-15

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Moscow City Oncology Hospital No. 62

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Istra, Moscow Oblast, Russia

Countries

Russia

References

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.

Reference Type: RESULT

PMID: 38697821 (View on PubMed)

Related Links

https://www.linkos.cz/english-summary/klinicka-onkologie-journal/2024-04-15-2-en/prizpusobeni-pooperacni-lecby-pomoci-biopsie-sentinelove-lymfaticke-uzliny-u-kar-1/

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.

Other Identifiers

MCOH62-07-08-21

Identifier Type: -

Identifier Source: org_study_id