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The value of sentinel lymphnode mapping with ICG in endometrial cancer

Sentinel lymphnode mapping with indocyanine green (ICG) in endometrial cancer: detection rate of sentinel lympnodes and learning curve of surgical procedure.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619000979156
Enrollment
212
Registered
2019-07-09
Start date
2019-09-06
Completion date
2022-10-28
Last updated
2023-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

HYPTOHESIS: Sentinel lymph node biopsy (SLB) with Indocyanine green (ICG) mapping is a valuable tool in endometrial cancer patients for pathological staging of the disease which improves short-term and long-term outcomes. AIM: To determine the value of SLB in endometrial cancer staging and to evaluate short and long - term treatment outcomes. TASKS: 1. To determine the influence of body mass index (BMI) and uterine or uterine cervix comorbidities on the detection rate of sentinel lymph node mapped with ICG. 2. To evaluate the incidence rate of micro-metastasis and isolated tumour cells (ITC) in SLB and its coherency with local spread of the endometrial cancer. 3. To evaluate the surgeons learning curve in detecting and resecting SLB mapped with ICG. METHODS: It is a prospective interventional study that is carried out in Lithuanian University of Health Sciences Hospital, Obstetrics and gynaecology Department. Inclusion criteria: - histologically confirmed high risk endometrial carcinoma of the uterus (G 2-3), non-endometrioid carcinoma, carcinosarcoma; - clinically staged non less than stage I B (FIGO) uterine carcinoma. Exclusion criteria: - surgery is done by laparotomy. For patients undergoing surgical treatment for endometrial cancer - total laparoscopic hysterectomy with bilateral adnexectomy and pelvic lymphadenectomy - indocyanine green dye (ICG) will be used to map sentinel lymph nodes: 1ml of ICG will be injected in 4 points of uterine cervix mucosa and stroma. During laparoscopic surgery in near-infrared light sentinel lymph nodes will be visualised and resected before proceeding with next steps of the surgery - total pelvic lymphadenectomy and hysterectomy. Sentinel lymph nodes will be examined by pathologist using ultra-staging protocol to find micro-metastasis and isolated tumour cells (ITC).

Interventions

For patients undergoing surgical treatment for endometrial cancer - total laparoscopic hysterectomy with bilateral adnexectomy and pelvic lymphadenectomy - indocyanine green dye (ICG) will be used to map sentinel lymph nodes: 1ml of ICG will be injected in 4 points of uterine cervix mucosa and stroma. Durign laparoscopic surgery in near infrared light a sentinel lymph nodes will be visualised and resected before proceeding with next surgery steps - total pelvic lymphadenectomy and hysterectomy.

For patients undergoing surgical treatment for endometrial cancer - total laparoscopic hysterectomy with bilateral adnexectomy and pelvic lymphadenectomy - indocyanine green dye (ICG) will be used to map sentinel lymph nodes: 1ml of ICG will be injected in 4 points of uterine cervix mucosa and stroma. Durign laparoscopic surgery in near infrared light a sentinel lymph nodes will be visualised and resected before proceeding with next surgery steps - total pelvic lymphadenectomy and hysterectomy. Duration of mapping procedure and sentinel lymphonode resection is aproximately 50 - 60 minutes. This procedure will be performed by the surgeon. Sentinel lymph nodes will be examined by pathologist using ultrastaging protocol to find micrometasis and isolated tumur cells (ITC)

Sponsors

Lithuanian University of Health sciences
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Primary purpose
Diagnosis

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patients who are diagnosed with: 1. Histologically confirmed high risk uterine endometrial carcinoma (G 2 -3) or non-endometrioid carcinoma; 2. Clinically staged >/- FIGO stage I B uterine carcinoma Type of surgery planned: totally laproscopic histerectomy/ laparoscopic asssisted vaginal hysterectomy and full systemic lymphadenectomy

Exclusion criteria

Planned surgery - laparotomy

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 11, 2026