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Completed

NCT Number: NCT03452982

Sentinel Lymph Node in Early Ovarian Cancer

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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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sentinel node technique

Other

Injection of a tracer in the stump of the infundibulo-pelvic ligament and uterus-ovary for sentinel node detection.

Primary outcomes

  1. Feasibility of performing the sentinel node technique (Detection rate)

    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.

Secondary outcomes

  1. Rate of realization of the technique

    Time frame: Intraoperative (day 0)

  2. Rate of realization of the technique

    Time frame: After anatomopathological study (day 30)

  3. Anatomical location of the sentinel node(s)

    Time frame: Intraoperative (day 0)

    Assessed by radiation (99Tc-nanocoloides) and staining with indocyanine green

  4. Anatomical location of the sentinel node(s)

    Time frame: After anatomopathological study (day 30)

    Assessed by the pathologist

  5. Number of detected sentinel nodes

    Time frame: Intraoperative (day 1)

  6. Number of detected sentinel nodes

    Time frame: After anatomopathological study (day 30)

  7. Characterization of the sample by collecting baseline characteristics

    Time frame: Screening (day 0)

    Age (years)

  8. Characterization of the sample by collecting baseline characteristics

    Time frame: Screening (day 0)

    Weight (kilograms)

  9. Characterization of the sample by collecting baseline characteristics

    Time frame: Screening (day 0)

    Height (centimeters)

  10. Characterization of the sample by collecting baseline characteristics

    Time frame: Screening (day 0)

    BMI (kg/m^2)

  11. Characterization of the sample by collecting baseline characteristics

    Time frame: Screening (day 0)

    Previous gynecological surgery and previous pathological anatomy

  12. Characterization of the sample by collecting tumor markers

    Time frame: Day 0

    Ca 125 and Ca 19.9.

  13. Characterization of the sample by collecting intraoperative findings

    Time frame: Day 0

    Ascites (milliliters)

  14. Characterization of the sample by collecting intraoperative findings

    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.

  15. Characterization of the sample by collecting surgical procedures

    Time frame: Day 0

    Hysterectomy, adnexectomy, appendectomy, peritonectomy / peritoneal biopsy, omentectomy, lymphadenectomy and blood transfusion (Realized or Unrealized)

  16. Characterization of the sample by collecting surgical procedures

    Time frame: Day 0

    Intraoperative complications

  17. Characterization of the sample by collecting surgical procedures

    Time frame: Day 0

    Result of intraoperative biopsy (unrealized, malignant, benign)

  18. Characterization of the sample by collecting surgical procedures

    Time frame: Day 0

    Estimated blood loss (milliliters)

  19. Characterization of the sample by collecting surgical procedures

    Time frame: Day 0

    Surgical time (minutes)

Sponsors and collaborators

Lead sponsor

Instituto de Investigacion Sanitaria La Fe

Other

Registry information

Acronym: SENTOV

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 2, 2018
Registry last updated
Oct 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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