Back to results[SENTRY] Tailoring Postoperative Management Through Sentinel Lymph Node Biopsy in Low- and Intermediate-Risk Endometrial Cancer (SENTRY)
Primary Purpose
Endometrial Cancer, Endometrial Neoplasms, Endometrial Adenocarcinoma
Status
Active
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Laparoscopic total hysterectomy with bilateral salpingo-oophorectomy and sentinel lymph node biopsy
Sponsored by
About this trial
This is an interventional treatment trial for Endometrial Cancer focused on measuring Endometrial Cancer, Endometrial Adenocarcinoma, Sentinel Lymph Node Biopsy, Laparoscopic Hysterectomy, Adjuvant Therapy, FIGO
Eligibility Criteria
Inclusion Criteria:
- Age ≥18
- Histologically verified low-grade endometrial adenocarcinoma of the endometrium (G1-G2)
- Stage IA (FIGO 2009) according to MRI (CT, ultrasound)
- Stage IB and II (FIGO 2009) when lymphadenectomy is contraindicated
- No contraindications for surgery
- Signed informed consent
Exclusion Criteria:
- Age <18
- Signs of tumor spread outside the corpus uteri
- No signs of tumor invasion into the myometrium
- High-grade tumor (G3)
- Bokhman type 2 tumor (serous adenocarcinoma, clear cell adenocarcinoma, carcinosarcoma, endometrial stromal sarcoma, etc.)
- Preoperative treatment of endometrial cancer (radiation therapy, chemotherapy or hormone therapy)
- Prior pelvic or retroperitoneal lymphadenectomy
- Prior surgery on the uterus and uterine appendages (except for cesarean section, tubectomy, ovariectomy, ovarian resection, ovarian biopsy, ovarian cauterization)
- Surgical treatment is contraindicated
- Allergy to iodine-containing drugs
- No signed informed consent
Sites / Locations
- 1. Department of Gynecologic Oncology, Moscow City Oncology Hospital No. 62
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Laparoscopic total hysterectomy with bilateral salpingo-oophorectomy and sentinel lymph node biopsy
Arm Description
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).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Adjustments in FIGO staging
The rate of change in disease stage based on SLNB results and postoperative histology (percentage).
Bilateral SLN detection
The rate of bilateral SLN detection (percentage).
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).
The rate of intraoperative complications of SLN biopsy
Percentage of patients experiencing intraoperative complications associated with SLN mapping and biopsy listed above.
Major postoperative morbidity
Major postoperative morbidity following the procedure (percentage).
Postoperative mortality
Postoperative mortality following the procedure (percentage).
Incidence of lymphedema
The rate of lower extremities lymphedema (percentage).
Pelvic recurrence rate
The percentage of patients experiencing pelvic recurrence after surgical treatment.
Time to pelvic recurrence
Time from surgical treatment to detected pelvic recurrence in months.
Full Information
NCT ID
NCT04972682
First Posted
July 12, 2021
Last Updated
October 6, 2023
Sponsor
Moscow City Oncology Hospital No. 62
1. Study Identification
Unique Protocol Identification Number
NCT04972682
Brief Title
[SENTRY] Tailoring Postoperative Management Through Sentinel Lymph Node Biopsy in Low- and Intermediate-Risk Endometrial Cancer
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
August 15, 2023 (Actual)
Study Completion Date
March 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Moscow City Oncology Hospital No. 62
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A single-center prospective open-label single-arm clinical trial
Masking
None (Open Label)
Allocation
N/A
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Laparoscopic total hysterectomy with bilateral salpingo-oophorectomy and sentinel lymph node biopsy
Arm Type
Experimental
Arm Description
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).
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic total hysterectomy with bilateral salpingo-oophorectomy and sentinel lymph node biopsy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in postoperative treatment strategy
Description
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 Outcome Measure Information:
Title
Adjustments in FIGO staging
Description
The rate of change in disease stage based on SLNB results and postoperative histology (percentage).
Time Frame
Up to 3 weeks after surgery
Title
Bilateral SLN detection
Description
The rate of bilateral SLN detection (percentage).
Time Frame
At the end of the surgery - 1 day
Title
Details of intraoperative complications of SLN biopsy
Description
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
Title
The rate of intraoperative complications of SLN biopsy
Description
Percentage of patients experiencing intraoperative complications associated with SLN mapping and biopsy listed above.
Time Frame
At the end of the surgery - 1 day
Title
Major postoperative morbidity
Description
Major postoperative morbidity following the procedure (percentage).
Time Frame
Up to 30 days after surgery
Title
Postoperative mortality
Description
Postoperative mortality following the procedure (percentage).
Time Frame
Up to 30 days after surgery
Title
Incidence of lymphedema
Description
The rate of lower extremities lymphedema (percentage).
Time Frame
Up to 24 months after surgery
Title
Pelvic recurrence rate
Description
The percentage of patients experiencing pelvic recurrence after surgical treatment.
Time Frame
24 months after surgery
Title
Time to pelvic recurrence
Description
Time from surgical treatment to detected pelvic recurrence in months.
Time Frame
24 months after surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
1. Department of Gynecologic Oncology, Moscow City Oncology Hospital No. 62
City
Istra
State/Province
Moskovskaya Oblast
ZIP/Postal Code
143515
Country
Russian Federation
12. IPD Sharing Statement
Learn more about this trial
[SENTRY] Tailoring Postoperative Management Through Sentinel Lymph Node Biopsy in Low- and Intermediate-Risk Endometrial Cancer
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