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

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano165 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

165

Conditions

Endometrial Cancer

Interventions

Hysteroscopic injectionPROCEDURE

Hysteroscopic injection

Cervical injectionPROCEDURE

Cervical injection

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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.

Locations (1)

Fondazione IRCCS Istituto Nazionale Tumori

Milan, Italy

Outcomes

Primary Outcomes

Detection rate

assessment of Detection rate in the para-aortic area

Time frame: 30 month

Secondary Outcomes

Detection rate

Detection rate in the pelvic area

Time frame: 30 month

Operative time

Operative time to detect and remove sentinel node

Time frame: 30 month

Intraoperative complications

Intraoperative complications during the sentinel lymph node dissection

Time frame: 30 month

Postoperative complications

Postoperative complications graded per the Clavien-Dindo Classification system

Time frame: 30 month

Data from ClinicalTrials.gov

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