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

Israel Healthcare Foundation

Status: Completed

Conditions: Endometrial Endometroid Carcinoma

Treatments: Device: Intraoperative ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT02407535

CMC-14-0059-CTIL

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Endometrial carcinoma patient

Experimental group

Treatment:

Device: Intraoperative ultrasound