N/A
N=22
Sentinel Node Detection in Clinical Early Stage Ovarian Cancer
Ovarian Cancer · Sentinel Node
Bottom Line
View on ClinicalTrials.gov: NCT01734746 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Nov 2018
Primary outcome: Primary: Number of Patients (%) in Which Sentinel Node(s) Are Detected After Injection of Blue Dye and Tracer in the Ovarian Ligaments. — 21 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Tracerinjection (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Maastricht University Medical Center
- Primary completion
- Oct 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients (%) in Which Sentinel Node(s) Are Detected After Injection of Blue Dye and Tracer in the Ovarian Ligaments. |
21 | — |
| SECONDARY Anatomical Location(s) of the Sentinel Nodes. |
14; 2; 5 | — |
Summary
As most cancers, ovarian cancer also spreads to regional lymph nodes. The concept of sentinel lymph node surgery is to see whether the cancer has spread to the very first lymph node or sentinel node (SN). If the sentinel node does not contain cancer, there is a high likelihood that the cancer has not spread to other lymph nodes. This means that, at least theoretically, a radical lymphadenectomy could be omitted and thus the associated morbidity. The sentinel node technique has been proven to be effective in different cancers such as breast cancer and malignant melanoma. In gynaecological tumors it has been shown to be effective in vulvar cancer. Currently sentinel node studies are done for cervix and uterine cancer.
The present study determines whether or not a sentinel node procedure in patients with ovarian cancer is feasible when the tracers are injected in the ovarian ligaments.
Eligibility Criteria
Inclusion Criteria
- Patients with a high suspicion of a malignant ovarian tumour planned for exploratory laparotomy.
- Patients with high-risk endometrial cancer in whom a staging laparotomy is planned.
- Age between 18 and 85 years.
Exclusion Criteria
- Previous surgery of both ovaries.
- Previous vascular surgery of the aorta, caval vein, and/or iliac vessels.
- Previous lymphadenectomy of lymph node sampling in the iliac or para-aortal region.
- History of a malignant lymphoma.
- History of a malignant tumour in the abdominal cavity.
- Previous allergic reaction to blue dye.
- Pregnant or lactating patients.
- An allergy for human albumin.
Data sourced from ClinicalTrials.gov (NCT01734746). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.