Sentinel Lymph Node in Early Ovarian Cancer

Instituto de Investigacion Sanitaria La Fe20 enrolled

Overview

This research study evaluates the concordance of the result between two diagnostic tests: Sentinel node and Pelvic-para-aortic lymphadenectomy in patients with ovarian cancer.

The objective of this study is to describe the feasibility of performing the sentinel node technique (Detection rate) in patients with early stage ovarian cancer. With this research study it will be evaluated the concordance of the result between two diagnostic tests: Sentinel node and Pelvic-para-aortic lymphadenectomy in patients with ovarian cancer.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Ovarian Cancer

Interventions

sentinel node techniqueOTHER

Injection of a tracer in the stump of the infundibulo-pelvic ligament and uterus-ovary for sentinel node detection.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Informed consent signed previously to performing any procedure related to the clinical trial. * Patients who are women 18 years of age or older at the moment of the randomization. * Patients with anatomopathological diagnosis of malignant ovarian tumor in a deferred study proposals for staging surgery or patients with suspicious tumor of malignancy who are going to be subjected to exploratory lapaotomy or laparoscopy and operative biopsy, and in the case this is positive, surgery of staging will be performed . Exclusion Criteria: * Informed consent not obtained or withdraw. * Benign result in extemporaneous study * Previous history of vascular surgery in the aorta, cava or pelvic vessels * Previous pelvic or para-aortic lymphadenectomy * Previous lymphoma * Previous abdomino-pelvic tumor * Previous allergic reaction to indocyanine green * Pregnancy / lactation * Severe adherent syndrome

Locations (1)

Hospital Universitario y Politécnico La Fe

Valencia, Spain

Outcomes

Primary Outcomes

Feasibility of performing the sentinel node technique (Detection rate)

The objective of this study is to describe the feasibility of performing the sentinel node technique (Detection rate) in patients with previous ovarian surgery injecting the tracer in the stump of the infundibulo-pelvic ligament and uterus-ovary for sentinel node detection.

Time frame: Intraoperative (day 0)

Secondary Outcomes

Rate of realization of the technique

Time frame: Intraoperative (day 0)

Rate of realization of the technique

Time frame: After anatomopathological study (day 30)

Anatomical location of the sentinel node(s)

Assessed by radiation (99Tc-nanocoloides) and staining with indocyanine green

Time frame: Intraoperative (day 0)

Anatomical location of the sentinel node(s)

Assessed by the pathologist

Time frame: After anatomopathological study (day 30)

Number of detected sentinel nodes

Time frame: Intraoperative (day 1)

Number of detected sentinel nodes

Time frame: After anatomopathological study (day 30)

Characterization of the sample by collecting baseline characteristics

Age (years)

Time frame: Screening (day 0)

Characterization of the sample by collecting baseline characteristics

Data from ClinicalTrials.gov

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