Ovarian Cancer
Conditions
Keywords
SENTINEL LYMPH NODE
Brief summary
This research study evaluates the concordance of the result between two diagnostic tests: Sentinel node and Pelvic-para-aortic lymphadenectomy in patients with ovarian cancer.
Detailed description
The objective of this study is to describe the feasibility of performing the sentinel node technique (Detection rate) in patients with early stage ovarian cancer. With this research study it will be evaluated the concordance of the result between two diagnostic tests: Sentinel node and Pelvic-para-aortic lymphadenectomy in patients with ovarian cancer.
Interventions
Injection of a tracer in the stump of the infundibulo-pelvic ligament and uterus-ovary for sentinel node detection.
Sponsors
Instituto de Investigacion Sanitaria La Fe
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Controlled, prospective, descriptive and not randomized
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Informed consent signed previously to performing any procedure related to the clinical trial. * Patients who are women 18 years of age or older at the moment of the randomization. * Patients with anatomopathological diagnosis of malignant ovarian tumor in a deferred study proposals for staging surgery or patients with suspicious tumor of malignancy who are going to be subjected to exploratory lapaotomy or laparoscopy and operative biopsy, and in the case this is positive, surgery of staging will be performed .
Exclusion criteria
* Informed consent not obtained or withdraw. * Benign result in extemporaneous study * Previous history of vascular surgery in the aorta, cava or pelvic vessels * Previous pelvic or para-aortic lymphadenectomy * Previous lymphoma * Previous abdomino-pelvic tumor * Previous allergic reaction to indocyanine green * Pregnancy / lactation * Severe adherent syndrome
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of performing the sentinel node technique (Detection rate) | Intraoperative (day 0) | The objective of this study is to describe the feasibility of performing the sentinel node technique (Detection rate) in patients with previous ovarian surgery injecting the tracer in the stump of the infundibulo-pelvic ligament and uterus-ovary for sentinel node detection. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anatomical location of the sentinel node(s) | Intraoperative (day 0) | Assessed by radiation (99Tc-nanocoloides) and staining with indocyanine green |
| Number of detected sentinel nodes | Intraoperative (day 1) | — |
| Characterization of the sample by collecting baseline characteristics | Screening (day 0) | Age (years) |
| Rate of realization of the technique | Intraoperative (day 0) | — |
| Characterization of the sample by collecting intraoperative findings | Day 0 | Ascites (milliliters) |
| Characterization of the sample by collecting surgical procedures | Day 0 | Hysterectomy, adnexectomy, appendectomy, peritonectomy / peritoneal biopsy, omentectomy, lymphadenectomy and blood transfusion (Realized or Unrealized) |
| Characterization of the sample by collecting tumor markers | Day 0 | Ca 125 and Ca 19.9. |
Countries
Spain
Outcome results
None listed