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

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.

Study Overview

• Status: Completed
• Conditions: Endometrial Endometroid Carcinoma
• Intervention / Treatment: Device: Intraoperative ultrasound

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel
    • Carmel Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Endometrial carcinoma patient	Device: Intraoperative ultrasound; Diagnostic intraoperative ultrasound in the uterus after hysterectomy for assessing depth of tumor invasion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Carmel Medical Center
• Investigators: Principal Investigator: Ido Feferkorn, MD, Carmel Medical Center

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): June 1, 2018
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: March 12, 2015
• First Submitted That Met QC Criteria: April 1, 2015
• First Posted (Estimate): April 3, 2015

Study Record Updates

• Last Update Posted (Actual): July 20, 2018
• Last Update Submitted That Met QC Criteria: July 19, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Carcinoma
• Other Study ID Numbers: CMC-14-0059-CTIL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO