Role of Sentinel lymph node biopsy in endometrial cancer

Not Applicable

Conditions: Health Condition 1: C541- Malignant neoplasm of endometrium

Registration Number: CTRI/2023/03/050608

Lead Sponsor: Department of Atomic Energy- CTC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

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

1) Patients who do not consent for the procedure.

2) Uterine confined, low risk endometrial cancer patients with T max size <2 cm, low grade (grade I/II), with no / minimal superficial myoinvasion will be excluded from the study since as per the current institutional protocol, lymphnode staging is omitted in these cases.

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.To evaluate the SLN detection rates(DR) <br/ ><br>i.Patient specific <br/ ><br>ii.Side specific <br/ ><br>iii.Bilateral <br/ ><br>2.To calculate the sensitivity (Sn), false negative rate (FNR) and negative predictive value (NPV) of SLNM algorithm.Timepoint: 30 days

Secondary Outcome Measures

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