Sentinel Lymph Node Assessment in Ovarian Cancer (TRSGO-SLN-OO5)

Acibadem University

Status: Unknown

Conditions: Sentinel Lymph Node; Ovarian Cancer

Treatments: Diagnostic Test: Sentinel lymph node detection

Study type: Interventional

Funder types: Other

Identifiers

NCT04714931

TRSGO-SLN-OO5

Details and patient eligibility

About

The aim of the study to evaluate the feasibility and accuracy of sentinel lymph node technique in ovarian cancer.

Full description

Systematic pelvic and paraaortic lymphadenectomy is commonly performed in ovarian cancer patients. However, in early ovarian cancer systematic lymphadenectomy can be an unnecessary procedure which can cause perioperative morbidity and mortality. In the other hand, initially diagnosed early stage ovarian cancer can be upstaged after staging surgery with systematic lymphadenectomy. For preventing unnecessary lymphadenectomy in early ovarian cancer, sentinel lymph node procedure may be an alternative which can prevent major complications without missing the real stage of the disease.

Aim of our study is to assess the feasibility and accuracy of lymph node evaluation with sentinel lymph node technique in early ovarian cancer patients. Pelvic and paraaortic spaces will be evaluated for the sentinel lymph nodes after the injection of the tracers in infundibulopelvic and utero-ovarian ligaments. Than routine systematic pelvic and paraaortic lymphadenectomy will be performed with the routine practice.

Enrollment: 200 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with Early stage ovarian cancer

Exclusion criteria

• Patient who had been administrated chemotherapy prior to surgery
• Patients who had diagnosed with malignancy other than ovarian cancer.
• Patients who had undergone pelvic or paraaortic lymphadenectomy or surgery prior to surgery.
• Patients who have allergy for the tracers.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Sentinel Lymph Node

Other group

Description:

Sentinel lymph nodes which can be identified with the tracer involvement will be removed. Then, systematic lymphadenectomy will be performed according to the routine practice.

Treatment:

Diagnostic Test: Sentinel lymph node detection