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Open Access Study protocol

Sentinel node in ovarian cancer: study protocol for a phase 1 study

Marjolein Kleppe1, Toon Van Gorp12, Brigitte FM Slangen12, Arnold J Kruse12, Boudewijn Brans3, Ivo NA Pooters3, Koen K Van de Vijver24 and Roy FPM Kruitwagen12*

Author Affiliations

1 Department of Obstetrics and Gynecology, Maastricht University Medical Centre, PO Box 5800 6202 AZ, Maastricht, The Netherlands

2 GROW, School for Oncology and Developmental Biology, Maastricht, The Netherlands

3 Department of Nuclear Medicine, Maastricht University Medical Centre, Maastricht, The Netherlands

4 Department of Pathology, Maastricht University Medical Centre, Maastricht, The Netherlands

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Trials 2013, 14:47  doi:10.1186/1745-6215-14-47

Published: 15 February 2013

Abstract

Background

The concept of sentinel lymph node surgery is to determine whether the cancer has spread to the very first lymph node or sentinel node. If the sentinel node does not contain cancer, then there is a high likelihood that the cancer has not spread to other lymph nodes. The sentinel node technique has been proven to be effective in different types of cancer. In this study we want to determine whether a sentinel node procedure in patients with ovarian cancer is feasible when the tracers are injected into the ovarian ligaments.

Methods/Design

Patients with a high likelihood of having an ovarian malignancy in whom a median laparotomy and a frozen section analysis is planned and patients with endometrial cancer in whom a staging laparotomy is planned will be included.

Before starting the surgical staging procedure, blue dye and radioactive colloid will be injected into the ligamentum ovarii proprium and the ligamentum infundibulo-pelvicum. In the analysis we calculate the percentage of patients in whom it is feasible to identify sentinel nodes. Other study parameters are the anatomical localization of the sentinel node(s) and the incidence of false negative lymph nodes.

Trial registration

Approval number: NL40323.068.12

Name: Medical Ethical Committee Maastricht University Hospital, University of Maastricht

Affiliation: Maastricht University Hospital

Board Chair Name: Medisch Ethische Commissie azM/UM

Keywords:
Sentinel node; Ovarian cancer