Status:
COMPLETED
Sentinel Lymph Node in Early Ovarian Cancer
Lead Sponsor:
Instituto de Investigacion Sanitaria La Fe
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 23 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 21 2019
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03452982
Start Date
March 23 2018
End Date
August 21 2019
Last Update
October 18 2019
Active Locations (1)
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1
Hospital Universitario y Politécnico La Fe
Valencia, Spain, 46026