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

Not Applicable

Completed

• Conditions: Endometrial Endometroid Carcinoma
• Interventions: Device: Intraoperative ultrasound

• Registration Number: NCT02407535
• Lead Sponsor: Carmel Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-03-12
• Study First Submitted QC: 2015-04-01
• Study First Posted: 2015-04-03
• Primary Completion: 2018-06-01
• Study Completion: 2018-06-01
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-19
• Last Update Posted: 2018-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Endometrial carcinoma patient	Intraoperative ultrasound	-

Primary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Carmel Medical Center; 🇮🇱 Haifa, Israel