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Role of Sentinel lymph node biopsy in endometrial cancer

Diagnostic performance of sentinel lymphnode mapping algorithm in early stage endometrial cancer.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/03/050608
Enrollment
100
Registered
2023-03-13
Start date
Unknown
Completion date
Unknown
Last updated
2023-04-03

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

Conditions

Health Condition 1: C541- Malignant neoplasm of endometrium

Interventions

Intervention1: Not applicable: Not applicable Control Intervention1: Not applicable.: Not applicable.

Sponsors

Department of Atomic Energy- CTC
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1)Patients who are between 18 â?? 80 yrs of age. 2)Patients with clinical and/or radiological stage I or II carcinoma endometrium. 3)Patients who are planned for primary surgical staging (open /MIS) at TMH/ACTREC. 4) Patients who have a preoperative pathology proof of carcinoma endometrium in the form of endometrial biopsy which has been either done in TMH/ACTREC or has undergone pathological review at TMH/ACTREC 5) Patients with any histological subtype (endometrioid, serous, clear cell, carcinosarcoma). 6) Patients with any histological grade.

Exclusion criteria

Exclusion criteria: 1) Patients who do not consent for the procedure. 2) Uterine confined, low risk endometrial cancer patients with T max size 3) Patients with locally advanced disease/ enlarged or suspicious lymph nodes/ intra-abdominal/ distant metastasis on pre-operative or intra-operative assessment. 4) Patients with previous surgeries/ procedures impairing lymphatic drainage (myomectomy/ retroperitoneal surgery/ abdominopelvic radiotherapy). 5) Patients with known allergy to iodine. 6) Patients with liver disease. 7) Patients with pre-existing lymphedema

Design outcomes

Primary

MeasureTime frame
1.To evaluate the SLN detection rates(DR) i.Patient specific ii.Side specific iii.Bilateral 2.To calculate the sensitivity (Sn), false negative rate (FNR) and negative predictive value (NPV) of SLNM algorithm.Timepoint: 30 days—

Secondary

MeasureTime frame
1.To calculate the sensitivity (Sn), false negative rate (FNR) and negative predictive value (NPV) of sentinel lymph node biopsy (SLNB). 2. To evaluate intra-operative and post-operative surgical morbidity (30 days) 3.To evaluate the procedure related adverse events Timepoint: 30 days—

Countries

India

Contacts

Public ContactDr Amita Maheswari

Tata Memorial Centre

maheshwariamita@yahoo.com02224177191

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026