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

NCT04972682CompletedNAINTERVENTIONAL

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.

Key Facts

Lead Sponsor

Moscow City Oncology Hospital No. 62

Enrollment

102

Start Date

2021-07-01

Completion Date

2023-08-15

Study Type

INTERVENTIONAL

Official Title

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

Interventions

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

Conditions

Endometrial CancerEndometrial NeoplasmsEndometrial AdenocarcinomaEndometrial Cancer Stage IEndometrial Cancer Stage IIEndometrial Endometrioid AdenocarcinomaSentinel Lymph NodeHysterectomyLaparoscopic Hysterectomy

Eligibility

Age Range

18 Years+

Sex

FEMALE

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

Outcome Measures

Primary Outcomes

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.

Time frame: Up to 3 weeks after surgery

Secondary Outcomes

Adjustments in FIGO staging

The rate of change in disease stage based on SLNB results and postoperative histology (percentage).

Time frame: Up to 3 weeks after surgery

Bilateral SLN detection

The rate of bilateral SLN detection (percentage).

Time frame: 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).

Time frame: 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.

Time frame: At the end of the surgery - 1 day

Major postoperative morbidity

Major postoperative morbidity following the procedure (percentage).

Time frame: Up to 30 days after surgery

Postoperative mortality

Postoperative mortality following the procedure (percentage).

Time frame: Up to 30 days after surgery

Incidence of lymphedema

The rate of lower extremities lymphedema (percentage).

Time frame: Up to 24 months after surgery

Pelvic recurrence rate

The percentage of patients experiencing pelvic recurrence after surgical treatment.

Time frame: 24 months after surgery

Time to pelvic recurrence

Time from surgical treatment to detected pelvic recurrence in months.

Time frame: 24 months after surgery

Locations

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

Linked Diseases

Endometrial Neoplasms

Endometrial Neoplasms — a type of gynecological cancer.

Linked Papers

Tailoring postoperative management through sentinel lymph node biopsy in low- and intermediate-risk endometrial cancer – the SENTRY clinical trial

While total hysterectomy and bilateral salpingo-oophorectomy without lymph node staging are standard for low- and intermediate-risk endometrial cancer, certain histopathologic factors revealed after surgery can necessitate additional interventions. Our study assessed the influence of sentinel lymph node biopsy on postoperative decision-making. In the SENTRY trial (July 2021 - February 2023), we enrolled patients with International Federation of Gynaecology and Obstetrics (FIGO) stage IA-IB low-grade endometrioid endometrial cancer. Laparoscopic sentinel lymph node mapping using indocyanine green was performed alongside total hysterectomy with bilateral salpingo-oophorectomy. Subsequent management changes based on sentinel lymph node biopsy results were evaluated. The trial was registered at ClinicalTrials.gov (NCT04972682). Of the 100 enrolled participants, a bilateral detection rate of 91% was observed with a median detection time of 10 min (interquartile range 8-13 min). Sentinel lymph node metastases were found in 8% (N = 8) of participants. Postoperative FIGO staging increased in 15% (N = 15) and decreased in 5% (N = 5) of patients. Sentinel lymph node biopsy results altered the adjuvant treatment plan for 20% (N = 20): external beam radiotherapy was omitted in 12% (N = 12) while 6% (N = 6) had external beam radiotherapy +/- systemic chemotherapy added due to sentinel lymph node metastases. In 2% (N = 2), the external beam radiotherapy field was expanded with the paraaortic region. No intraoperative complications were reported and no 30-day major morbidity and mortality occurred. Throughout a median follow-up of 14 (95% CI 12-15 months, neither patient-reported lymphedema nor pelvic recurrence surfaced in the cohort. Sentinel lymph node biopsy using indocyanine green is a safe procedure and allows tailoring adjuvant therapy in presumed low- and intermediate-risk endometrial cancer. It assists in avoiding external beam radiotherapy overtreatment and introducing additional modalities when necessary.