Assessing the Ultrasound Done on a the Uterus After Hysterectomy as a Diagnostic Tool for the Depth of Endometrial Carcinoma Invasion Into the Myometrium
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Endometrial Endometroid Carcinoma
- Sponsor
- Carmel Medical Center
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Tumor invasion
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Ido Feferkorn
MD
Carmel Medical Center
Eligibility Criteria
Inclusion Criteria
- •Patient's age is 18 or above
- •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.
- •Patient able to understand,read and sign informed consent.
- •Patient is not participating in other medical trials at present or in the past 30 days
Exclusion Criteria
- •Age under 18 years
- •Patients assessed preoperatively to be at stage 2 and higher endometrial carcinoma
- •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
Outcomes
Primary Outcomes
Tumor invasion
Time Frame: 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)