Assessing Uterine Ultrasound Done as a Diagnostic Tool for the Depth of Carcinoma Invasion

Carmel Medical Center20 enrolled

Overview

In this study the investigators aim to assess the diagnostic performance of intraoperative, ultrasonographic assessment of the surgical extracted uterus for determining myometrial invasion's depth in comparison to preoperative ultrasound, intraoperative gross inspection and final pathological report (gold standard). The investigators hope that intraoperative gross inspection of the extracted uterus might offer an additional intraoperative tool for assessing the need for pelvic lymphadenectomy in early stage of endometrial cancer at least as good as pathological exam.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Endometrial Endometroid Carcinoma

Interventions

Intraoperative ultrasoundDEVICE

Diagnostic intraoperative ultrasound in the uterus after hysterectomy for assessing depth of tumor invasion

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patient's age is 18 or above 2. Patient has been scheduled to undergo hysterectomy (laparoscopic or abdominal) for the staging and treatment of endometrial cancer (endometrioid subtype) and with the relevant suspected symptoms. 3. Patient able to understand,read and sign informed consent. 4. Patient is not participating in other medical trials at present or in the past 30 days Exclusion Criteria: 1. Age under 18 years 2. Patients assessed preoperatively to be at stage 2 and higher endometrial carcinoma 3. Subjects which their biopsy in the pre operating process will include high risk cell types: * Grade 3 endometrioid adenocarcinoma, * clear cell carcinoma * papillary serous carcinoma * carcinosarcoma

Locations (1)

Carmel Medical Center

Haifa, Israel

Outcomes

Primary Outcomes

Tumor invasion

Tumor invasion (in millimeters and in percentage of myometrial size) as assessed by ultrasound in comparison to macroscopic assesment during surgery and to final pathological report)

Time frame: Average of 2 weeks (immediate assessment by ultrasound, average of 2 weeks for final pathological report)

Data from ClinicalTrials.gov

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