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

Assessing the Ultrasound Done on a the Uterus After Hysterectomy as a Diagnostic Tool for the Depth of Endometrial Carcinoma Invasion Into the Myometrium

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02407535

Enrollment

Registered

2015-04-03

Start date

2015-03-31

Completion date

2018-06-01

Last updated

2018-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometrial Endometroid Carcinoma

Brief summary

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.

Interventions

DEVICEIntraoperative ultrasound

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Tumor invasion	Average of 2 weeks (immediate assessment by ultrasound, average of 2 weeks for final pathological report)	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)

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026