NCT03563781

SEntine Lymph Node in earLY Ovarian Cancer (SELLY)

SEntine Lymph Node in earLY Ovarian Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 176 (actual)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Sentinel Lymph Node
• Ovarian Cancer Stage I

Interventions

Type	Name	Description
PROCEDURE	Sentinel node detection	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.

Timeline

• Start date: 2017-11-11
• Primary completion: 2022-07-29
• Completion: 2023-05-05
• First posted: 2018-06-20
• Last updated: 2023-06-22

Locations

1 site across 1 country: Italy