Study protocol
Sentinel node in ovarian cancer: study protocol for a phase 1 study
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
Trials 2013, 14:47 doi:10.1186/1745-6215-14-47
Published: 15 February 2013Abstract
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
