SEntine Lymph Node in earLY Ovarian Cancer (SELLY)

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Completed

Conditions: Ovarian Cancer Stage I; Sentinel Lymph Node

Treatments: Procedure: Sentinel node detection

Study type: Interventional

Funder types: Other

Identifiers

NCT03563781

CICOG-2-3-18/12

Details and patient eligibility

About

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

Full description

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.

Enrollment: 176 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Epithelial ovarian cancer
• Early stage disease limited to the ovary

Exclusion criteria

• Evidence of extraovarian disease
• Allergy to the materials used

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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176 participants in 1 patient group

SENTINEL NODE

Other group

Description:

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)

Treatment:

Procedure: Sentinel node detection