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

Endometrial Endometroid Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02407535
• Other study ID #: CMC-14-0059-CTIL
• Status: Completed
• Phase: N/A
• Start date: March 2015
• Est. completion date: June 1, 2018

Study information

• Verified date: July 2018
• Source: Carmel Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 1, 2018
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Endometrial Endometroid Carcinoma

Intervention

Device:
• Intraoperative ultrasound
Diagnostic intraoperative ultrasound in the uterus after hysterectomy for assessing depth of tumor invasion

Locations

Country	Name	City	State
Israel	Carmel Medical Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Carmel Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Average of 2 weeks (immediate assessment by ultrasound, average of 2 weeks for final pathological report)