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SEntine Lymph Node in earLY Ovarian Cancer (SELLY) — SELLY  

Sentinel Lymph Node Clinical Trial

Official title:
SEntine Lymph Node in earLY Ovarian Cancer

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03563781
Study type Interventional
Source Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Contact
Status Completed
Phase N/A
Start date November 11, 2017
Completion date May 5, 2023
View Details
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