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Trials | Abstract | Sentinel node in ovarian cancer: study protocol for a phase 1 study
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
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 (Netherlands)
Affiliation: Maastricht University Hospital
Board Chair Name: Medisch Ethische Commissie azM/UM
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