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

NCT ID: NCT02407535

Last Updated: 2018-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2018-06-01

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.

Conditions

Endometrial Endometroid Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Endometrial carcinoma patient

Group Type: EXPERIMENTAL

Intraoperative ultrasound

Intervention Type: DEVICE

Diagnostic intraoperative ultrasound in the uterus after hysterectomy for assessing depth of tumor invasion

Interventions

Intraoperative ultrasound

Diagnostic intraoperative ultrasound in the uterus after hysterectomy for assessing depth of tumor invasion

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Carmel Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Ido Feferkorn

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ido Feferkorn, MD

Role: PRINCIPAL_INVESTIGATOR

Carmel Medical Center

Locations

Carmel Medical Center

Haifa, , Israel

Countries

Israel

Other Identifiers

CMC-14-0059-CTIL

Identifier Type: -

Identifier Source: org_study_id