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

Authors
  • Kleppe, Marjolein1
  • Van Gorp, Toon1, 2
  • Slangen, Brigitte FM1, 2
  • Kruse, Arnold J1, 2
  • Brans, Boudewijn3
  • Pooters, Ivo NA3
  • Van de Vijver, Koen K2, 4
  • Kruitwagen, Roy FPM1, 2
  • 1 Maastricht University Medical Centre, Department of Obstetrics and Gynecology, Maastricht, 6202 AZ, The Netherlands , Maastricht (Netherlands)
  • 2 GROW, School for Oncology and Developmental Biology, Maastricht, The Netherlands , Maastricht (Netherlands)
  • 3 Maastricht University Medical Centre, Department of Nuclear Medicine, Maastricht, The Netherlands , Maastricht (Netherlands)
  • 4 Maastricht University Medical Centre, Department of Pathology, Maastricht, The Netherlands , Maastricht (Netherlands)
Type
Published Article
Journal
Trials
Publisher
Springer (Biomed Central Ltd.)
Publication Date
Feb 15, 2013
Volume
14
Issue
1
Identifiers
DOI: 10.1186/1745-6215-14-47
Source
Springer Nature
Keywords
License
Yellow

Abstract

BackgroundThe 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/DesignPatients 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 registrationApproval number: NL40323.068.12Name: Medical Ethical Committee Maastricht University Hospital, University of MaastrichtAffiliation: Maastricht University HospitalBoard Chair Name: Medisch Ethische Commissie azM/UM

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