Mapping Sentinel Lymph Node in Initial Stages of Ovarian Cancer

Summary

Epithelial ovarian cancer (EOC) diagnosed in the initial stage (stage I-II) require complete staging surgery to histologically assess the possible existence of peritoneal or lymph node disease.

Systematic pelvic and paraaortic lymphadenectomy in stage I-II EOC is essential since confirming the presence of lymph node metastases means re-staging the disease as stage III. This change of stage has important prognostic and therapeutic implications. However, the lymph node involvement rate is around 10-30% (average of 15%). Systematic pelvic and para-aortic lymphadenectomy carries a risk of intraoperative complications, as well as longer operative time, postoperative complications and longer hospital stay. Moreover, by now there is no evidence suggesting a possible therapeutic value.

The sentinel lymph node (SLN) detects the first level of lymph node drainage. The absence of metastases in the SLN predicts the absence of tumor infiltration of the rest of lymph nodes of the same anatomical region and allows to safely avoid lymphadenectomy and its associated morbidity. In addition, the exhaustive evaluation of the SLN by ultrastaging and immunohistochemical study allows to increase the detection of microscopic disease.

Sentinel lymph node (SLN) biopsy, implemented in clinical practice in other gynecological tumors (breast, vulva, cervix or endometrium), has been studied very little in the initial ovarian epithelial cancer. Unlike other gynecological tumors, there are multiple anatomical and technical aspects that largely explain this lack of information. The double ovarian vascularization that accompanies lymphatic drainage explains this higher complexity. Therefore, at the present time, the detection of SLN in the initial EOC remains an experimental area without applicability in clinical practice. There are multiple doubts and issues to be resolved regarding the different tracers, the site and time injection and the actual accuracy of the SLN versus the lymphadenectomy.

Conditions

• Ovarian Cancer
• Sentinel Lymph Node

Interventions

PROCEDURE

Sentinel node detection

Injection of the radiotracer to infundibulo-pelvic and utero-ovarian ligament in patients with high suspicion of malignancy adnexal mass. Injection of green indocyanine r to infundibulo-pelvic and utero-ovarian stumps only in case of malignancy after the adnexectomy. Sentinel node exeresis and a complete staging surgery (including pelvic and para-aortic lymphadenectomy) will be performed in patients with ovarian cancer diagnosis.

Sponsors & Collaborators

• Berta Diaz-Feijoo

  collaborator UNKNOWN

• Aureli Torné

  collaborator UNKNOWN

• Pilar Paredes

  collaborator UNKNOWN

• Sergi Vidal-Sicart

  collaborator UNKNOWN

• Ariel Glickman

  collaborator UNKNOWN

• Pere Fusté

  collaborator UNKNOWN

• Tiermes Marina

  collaborator UNKNOWN

• Francisco Campos

  collaborator UNKNOWN

• Hospital Clinic of Barcelona

  lead OTHER

Principal Investigators

• Aureli Torné, PhD · Hospital Clinic of Barcelona

• Berta Díaz-Feijóo, PhD · Hospital Clinic of Barcelona

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-01-01

Primary Completion

2023-04-01

Completion

2023-05-01

Countries

• Spain

Study Locations