Sentinel Lymph Node in Early Ovarian Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Sentinel Lymph Node in Early Ovarian Cancer

Conditions
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Ovarian Cancer

Intervention / Treatment
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* Other: sentinel node technique


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Controlled, prospective, descriptive and not randomized
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with ovarian cancer<br>Injection of a tracer in the stump of the infundibulo-pelvic ligament and uterus-ovary for sentinel node detection | Other: sentinel node technique<br>* Injection of a tracer in the stump of the infundibulo-pelvic ligament and uterus-ovary for sentinel node detection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of performing the sentinel node technique (Detection rate) | 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. | Intraoperative (day 0) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of realization of the technique |  | Intraoperative (day 0) | 
| Rate of realization of the technique |  | After anatomopathological study (day 30) | 
| Anatomical location of the sentinel node(s) | Assessed by radiation (99Tc-nanocoloides) and staining with indocyanine green | Intraoperative (day 0) | 
| Anatomical location of the sentinel node(s) | Assessed by the pathologist | After anatomopathological study (day 30) | 
| Number of detected sentinel nodes |  | Intraoperative (day 1) | 
| Number of detected sentinel nodes |  | After anatomopathological study (day 30) | 
| Characterization of the sample by collecting baseline characteristics | Age (years) | Screening (day 0) | 
| Characterization of the sample by collecting baseline characteristics | Weight (kilograms) | Screening (day 0) | 
| Characterization of the sample by collecting baseline characteristics | Height (centimeters) | Screening (day 0) | 
| Characterization of the sample by collecting baseline characteristics | BMI (kg/m^2) | Screening (day 0) | 
| Characterization of the sample by collecting baseline characteristics | Previous gynecological surgery and previous pathological anatomy | Screening (day 0) | 
| Characterization of the sample by collecting tumor markers | Ca 125 and Ca 19.9. | Day 0 | 
| Characterization of the sample by collecting intraoperative findings | Ascites (milliliters) | Day 0 | 
| Characterization of the sample by collecting intraoperative findings | Tumor size (centimeters) of: right ovary, left ovary, right tube, left tube, uterus, pelvic nodes, para-aortic nodes, and tumor in upper hemiabdomen. | Day 0 | 
| Characterization of the sample by collecting surgical procedures | Hysterectomy, adnexectomy, appendectomy, peritonectomy / peritoneal biopsy, omentectomy, lymphadenectomy and blood transfusion (Realized or Unrealized) | Day 0 | 
| Characterization of the sample by collecting surgical procedures | Intraoperative complications | Day 0 | 
| Characterization of the sample by collecting surgical procedures | Result of intraoperative biopsy (unrealized, malignant, benign) | Day 0 | 
| Characterization of the sample by collecting surgical procedures | Estimated blood loss (milliliters) | Day 0 | 
| Characterization of the sample by collecting surgical procedures | Surgical time (minutes) | Day 0 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SENTINEL LYMPH NODE