Health Condition 1: C539- Malignant neoplasm of cervix uteri, unspecified
Conditions
Interventions
Intervention1: NIL: NIL
Control Intervention1: NIL: NIL
Sponsors
Tata Memorial Center
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 1. Inability to understand and/or consent for the procedure 2. ECOG 2 or more 3. Locally advanced disease/ enlarged or suspicious lymphnodes/ intrabdominal / distant metastasis on preoperative clinical assessment/ Ultrasonography/ CECT/ MRI pelvis/ chest X ray. Locally advanced disease detected intra operatively(bladder/ lateral parametrial/ uterosacral involvement/ intra peritoneal metastasis) Previous surgeries / procedures impairing lymphatic drainage (myomectomy/ retroperitoneal surgery/ abdominopelvic radiotherapy) Previous neo-adjuvant therapy chemotherapy/ radiotherapy. Allergy to iodine Known liver disease Pre-existing lymphoedema.
Design outcomes
Primary
| Measure | Time 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: after enrollment is completed | — |
Secondary
| Measure | Time frame |
|---|---|
| - To calculate the sensitivity (Sn), false negative rate (FNR) and negative predictive value (NPV) of sentinel lymph node biopsy (SLNB). - To calculate the sensitivity (Sn), false negative rate (FNR) and negative predictive value (NPV) of frozen section analysis (FSA) of SLNs. - To assess intra operative adverse events related to the procedure. Timepoint: after enrollment is completed | — |
Countries
India
Contacts
Public ContactDr Manisha Choudhary
Tata Memorial Hospital
Outcome results
None listed