SEntine Lymph Node in earLY Ovarian Cancer (SELLY)

Sentinel Lymph Node Clinical Trial

— SELLY  

Official title:

SEntine Lymph Node in earLY Ovarian Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03563781
• Other study ID #: CICOG-2-3-18/12
• Status: Completed
• Phase: N/A
• Start date: November 11, 2017
• Est. completion date: May 5, 2023

Study information

• Verified date: June 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: May 5, 2023
• Est. primary completion date: July 29, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Evidence of extraovarian disease
• Allergy to the materials used

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer Stage I
• Ovarian Neoplasms
• Sentinel Lymph Node

Intervention

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.

Locations

Country	Name	City	State
Italy	Giovannni Scambia	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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. — View 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. — View 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.2017.12.00 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with procedure-related adverse events	The number of patients with procedure-related adverse events as assessed by CTCAE v4.0	6 months
Primary	Detection rate	The rate of patients in whom the sentinel node is detected	24 months
Secondary	Negative predictive value	The negative predictive value of sentinel node in assessing nodal status	24 months