Hospital Universitario y Politécnico La Fe
Valencia, 46026, Spain
NCT Number: NCT03452982
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.
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Notify Me18 year and older
Female
Interventional
Phase 2
Valencia, 46026, Spain
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Injection of a tracer in the stump of the infundibulo-pelvic ligament and uterus-ovary for sentinel node detection.
Time frame: 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.
Time frame: Intraoperative (day 0)
Time frame: After anatomopathological study (day 30)
Time frame: Intraoperative (day 0)
Assessed by radiation (99Tc-nanocoloides) and staining with indocyanine green
Time frame: After anatomopathological study (day 30)
Assessed by the pathologist
Time frame: Intraoperative (day 1)
Time frame: After anatomopathological study (day 30)
Time frame: Screening (day 0)
Age (years)
Time frame: Screening (day 0)
Weight (kilograms)
Time frame: Screening (day 0)
Height (centimeters)
Time frame: Screening (day 0)
BMI (kg/m^2)
Time frame: Screening (day 0)
Previous gynecological surgery and previous pathological anatomy
Time frame: Day 0
Ca 125 and Ca 19.9.
Time frame: Day 0
Ascites (milliliters)
Time frame: Day 0
Tumor size (centimeters) of: right ovary, left ovary, right tube, left tube, uterus, pelvic nodes, para-aortic nodes, and tumor in upper hemiabdomen.
Time frame: Day 0
Hysterectomy, adnexectomy, appendectomy, peritonectomy / peritoneal biopsy, omentectomy, lymphadenectomy and blood transfusion (Realized or Unrealized)
Time frame: Day 0
Intraoperative complications
Time frame: Day 0
Result of intraoperative biopsy (unrealized, malignant, benign)
Time frame: Day 0
Estimated blood loss (milliliters)
Time frame: Day 0
Surgical time (minutes)
Instituto de Investigacion Sanitaria La Fe
Other
Acronym: SENTOV
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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