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

Endometrial Cancer Clinical Trial

— SENTRY  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04972682
• Other study ID #: MCOH62-07-08-21
• Status: Completed
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: April 15, 2024

Study information

• Verified date: April 2024
• Source: Moscow City Oncology Hospital No. 62
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: April 15, 2024
• Est. primary completion date: August 15, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Carcinoma, Endometrioid
• Endometrial Adenocarcinoma
• Endometrial Cancer
• Endometrial Cancer Stage I
• Endometrial Cancer Stage II
• Endometrial Endometrioid Adenocarcinoma
• Endometrial Neoplasms
• Hysterectomy
• Laparoscopic Hysterectomy
• Sentinel Lymph Node

Intervention

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.

Locations

Country	Name	City	State
Russian Federation	1. Department of Gynecologic Oncology, Moscow City Oncology Hospital No. 62	Istra	Moskovskaya Oblast

Sponsors (1)

Lead Sponsor	Collaborator
Moscow City Oncology Hospital No. 62

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Bilateral SLN detection	The rate of bilateral SLN detection (percentage).	At the end of the surgery - 1 day
Secondary	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
Secondary	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
Secondary	Major postoperative morbidity	Major postoperative morbidity following the procedure (percentage).	Up to 30 days after surgery
Secondary	Postoperative mortality	Postoperative mortality following the procedure (percentage).	Up to 30 days after surgery
Secondary	Incidence of lymphedema	The rate of lower extremities lymphedema (percentage).	Up to 24 months after surgery
Secondary	Pelvic recurrence rate	The percentage of patients experiencing pelvic recurrence after surgical treatment.	24 months after surgery
Secondary	Time to pelvic recurrence	Time from surgical treatment to detected pelvic recurrence in months.	24 months after surgery

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