SEntine Lymph Node in earLY Ovarian Cancer (SELLY)

Study Overview
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Brief Summary
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The present study aims at investigating the feasibility, the detection rate and the negative predictive value of sentinel node in predicting the presence or absence of lymph node metastasis in ovarian cancer patients

Detailed Description
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Patients with early stage ovarian cancer have a good prognosis. However, nearly 15% of the initially diagnosed as early stage ovarian cancers, will be upstaged after an appropriate surgical staging due to lymphatic metastasis, despite of preoperative radiological data. Therefore, complete pelvic and para-aortic lymphadenectomy in these patients represents a crucial procedure. On the other hand, nodal dissection may be associated with threatening intra- and post-operative complications. If feasible and accurate, the sentinel lymph node procedure could be a modality to avoid unnecessary radical lymphadenectomy without missing important information on nodal status. With the present study we aim at exploring the role of sentinel node dissection in early ovarian cancer patients. Patients with ovarian cancer macroscopically limited to the ovary (early ovarian cancer) will receive injection of a tracer (patent blue or indocyanine green) which have already been proven safe and extremely effective in several other gynecologic and non-gynecologic malignancies. Then the retroperitoneal spaces will be opened as for a standard lymphadenectomy procedure and the lymph node marked with the tracer will be identified. After dissection of the sentinel node, lymphadenectomy will be completed according to current guidelines. Operative data, pathological findings and accuracy of sentinel node in predicting nodal status will be registered.

Official Title
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SEntine Lymph Node in earLY Ovarian Cancer

Conditions
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Sentinel Lymph Node, Ovarian Cancer Stage I

Intervention / Treatment
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* Procedure: Sentinel node detection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Epithelial ovarian cancer Early stage disease limited to the ovary Exclusion Criteria: Evidence of extraovarian disease Allergy to the materials used

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: All patients with early ovarian cancer will receive sentinel node procedure before full lymphadenectomy, in order to assess the accuracy of sentinel node in diagnosing the presence of nodal metastases.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: SENTINEL NODE<br>Patients with ovarian cancer will receive sentinel node identification and they will be then submitted to complete pelvic and para-aortic lymphadenectomy (as per the present guidelines) | Procedure: Sentinel node detection<br>* Patients will receive injection of tracer in the ovarian ligaments to identify the lymphatic drainage of the affected ovary and ultimately the sentinel node. Afterwards, systematic lymphadenectomy will be accomplished according to current guidelines.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with procedure-related adverse events | The number of patients with procedure-related adverse events as assessed by CTCAE v4.0 | 6 months | 
| Detection rate | The rate of patients in whom the sentinel node is detected | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Negative predictive value | The negative predictive value of sentinel node in assessing nodal status | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ovarian cancer, laparoscopy, sentinel node, lymphadenectomy