Sentinel node in ovarian cancer.

Completed

Conditions: ovarian cancer
10038594

Registration Number: NL-OMON42766

Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 60

Inclusion Criteria

- Patients with a high suspicion of a malignant ovarian tumour planned for exploratory laparotomy with frozen section, staging procedure in case of malignancy.
- Patients in whom the ovarian malignant tumour has already been resected and a second surgical procedure is planned to complete the staging procedure including lymph nodes.

Exclusion Criteria

- Age <18
- Age > 85 years.
- Mentally incompetent to give informed consent.
- 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.
- An allergy for human albumin.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Percentage of patients in whom it is feasible to identify sentinel nodes in<br /><br>case the malignant ovarian mass has already been resected.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- To determine if blue colorization of the sentinel nodes is related to the<br /><br>time-interval between injection and retroperitoneal exploration?<br /><br>- To determine if the technique becomes more accurate by using a mobile<br /><br>gamma-camera and / or multimodality radioactive and fluorescence guidance<br /><br>during the surgical procedure.</p><br>