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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2022-04-01

Brief Summary

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

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Detailed Description

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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.

Conditions

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Ovarian Cancer Sentinel Lymph Node

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prospective, Controlled, not randomized

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Sentinel Lymph Node

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.

Group Type OTHER

Sentinel lymph node detection

Intervention Type DIAGNOSTIC_TEST

Tracer (Indocyanine green or blue dye) will be injected into the IP and utero-ovarian ligaments, after opening of the pelvic and paraaortic retroperitoneal spaces, 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.

Interventions

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Sentinel lymph node detection

Tracer (Indocyanine green or blue dye) will be injected into the IP and utero-ovarian ligaments, after opening of the pelvic and paraaortic retroperitoneal spaces, 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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No