Sentinel Lymph Node in Early Ovarian Cancer

Phase 2

Completed

• Conditions: Ovarian Cancer
• Interventions: Other: sentinel node technique

• Registration Number: NCT03452982
• Lead Sponsor: Instituto de Investigacion Sanitaria La Fe

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.

Study Timeline

• Study First Submitted: 2018-02-12
• Study First Submitted QC: 2018-02-26
• Study First Posted: 2018-03-02
• Study Start: 2018-03-23
• Status Verified: 2019-08
• Primary Completion: 2019-08-21
• Study Completion: 2019-08-21
• Last Update Submitted: 2019-10-17
• Last Update Posted: 2019-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with ovarian cancer	sentinel node technique	Injection of a tracer in the stump of the infundibulo-pelvic ligament and uterus-ovary for sentinel node detection

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Characterization of the sample by collecting baseline characteristics	Screening (day 0)	Previous gynecological surgery and previous pathological anatomy
Rate of realization of the technique	After anatomopathological study (day 30)
Anatomical location of the sentinel node(s)	After anatomopathological study (day 30)	Assessed by the pathologist
Number of detected sentinel nodes	After anatomopathological study (day 30)
Characterization of the sample by collecting tumor markers	Day 0	Ca 125 and Ca 19.9.
Characterization of the sample by collecting intraoperative findings	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.
Characterization of the sample by collecting surgical procedures	Day 0	Surgical time (minutes)

Trial Locations

Locations (1)

Hospital Universitario y Politécnico La Fe; 🇪🇸 Valencia, Spain