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SEntine Lymph Node in earLY Ovarian Cancer (SELLY)

SEntine Lymph Node in earLY Ovarian Cancer

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03563781
Acronym
SELLY
Enrollment
176
Registered
2018-06-20
Start date
2017-11-11
Completion date
2023-05-05
Last updated
2023-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Cancer Stage I, Sentinel Lymph Node

Keywords

ovarian cancer, laparoscopy, sentinel node, lymphadenectomy

Brief 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.

Interventions

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.

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Evidence of extraovarian disease * Allergy to the materials used

Design outcomes

Primary

MeasureTime frameDescription
Number of participants with procedure-related adverse events6 monthsThe number of patients with procedure-related adverse events as assessed by CTCAE v4.0
Detection rate24 monthsThe rate of patients in whom the sentinel node is detected

Secondary

MeasureTime frameDescription
Negative predictive value24 monthsThe negative predictive value of sentinel node in assessing nodal status

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026