Hysteroscopic vs. Cervical Injection for Sentinel Node Detection of Endometrial Cancer

Not Applicable

Completed

• Conditions: Endometrial Cancer

• Registration Number: NCT04302714
• Lead Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Brief Summary

Hysteroscopic vs. Cervical Injection for Sentinel Node Detection of Endometrial Cancer: a multicenter prospective randomized study

Detailed Description

Hysteroscopic vs. Cervical Injection for Sentinel Node Detection of Endometrial Cancer

Study Timeline

• Study Start: 2017-03-20
• Primary Completion: 2019-03-28
• Status Verified: 2020-02
• Study Completion: 2020-02-25
• Study First Submitted: 2020-02-26
• Study First Submitted QC: 2020-03-06
• Study First Posted: 2020-03-10
• Last Update Submitted: 2020-03-10
• Last Update Posted: 2020-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 165

Inclusion Criteria

• Signed informed consent from the patient;
• Histological diagnosis of endometrial cancer (including type I and II EC);
• Early stage (FIGO stage < 4);
• Age older than 18 years.

Exclusion Criteria

• Preoperative diagnosis of extra-uterine disease;
• Preoperative suspicious of gross positive nodes;
• Execution of neoadjuvant chemotherapy;
• Contraindication to upfront general anesthesia and or mini-invasive surgery;
• Systemic infections ongoing;
• Pregnancy ongoing.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Detection rate	30 month	assessment of Detection rate in the para-aortic area

Secondary Outcome Measures

Name	Time	Method
Detection rate	30 month	Detection rate in the pelvic area
Operative time	30 month	Operative time to detect and remove sentinel node
Intraoperative complications	30 month	Intraoperative complications during the sentinel lymph node dissection
Postoperative complications	30 month	Postoperative complications graded per the Clavien-Dindo Classification system

Trial Locations

Locations (1)

Fondazione IRCCS Istituto Nazionale Tumori; 🇮🇹 Milano, Italy