Clinical trial NCT03563781: SEntine Lymph Node in earLY Ovarian Cancer (SELLY)
Official title: SEntine Lymph Node in earLY Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sentinel Lymph Node
Ovarian Cancer Stage I
Keywords: ovarian cancer
laparoscopy
sentinel node
lymphadenectomy
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2018-06-20
Enrollment: 176
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Evidence of extraovarian disease
* Allergy to the materials used

Primary outcomes:
measure: Number of participants with procedure-related adverse events
timeFrame: 6 months
measure: Detection rate
timeFrame: 24 months
Secondary outcomes:
measure: Negative predictive value
timeFrame: 24 months
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Giovannni Scambia
Study officials:
affiliation: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
name: Giovanni Scambia, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Uccella S, Gisone B, Stevenazzi G, Ghezzi F. Laparoscopic sentinel node detection with ICG for early ovarian cancer: Description of a technique and literature review. Eur J Obstet Gynecol Reprod Biol. 2018 Feb;221:193-194. doi: 10.1016/j.ejogrb.2017.12.004. Epub 2017 Dec 6. No abstract available.
citation: Sadeghi R. Feasibility of Sentinel Node Mapping in Ovarian Tumors: What Is the Evidence? Int J Gynecol Cancer. 2018 Feb;28(2):421-422. doi: 10.1097/IGC.0000000000001158. No abstract available.
citation: Nyberg RH, Korkola P, Maenpaa JU. Sentinel Node and Ovarian Tumors: A Series of 20 Patients. Int J Gynecol Cancer. 2017 May;27(4):684-689. doi: 10.1097/IGC.0000000000000948.
citation: Scambia G, Nero C, Uccella S, Vizza E, Ghezzi F, Cosentino F, Chiantera V, Fagotti A. Sentinel-node biopsy in early stage ovarian cancer: a prospective multicentre study (SELLY). Int J Gynecol Cancer. 2019 Nov;29(9):1437-1439. doi: 10.1136/ijgc-2019-000886. Epub 2019 Oct 9.