Intrauterine Manipulator Use and Peritoneal Cytology in Endometrial Cancer

This study is looking at whether using a V-care® intrauterine manipulator during surgery for early-stage endometrial cancer (cancer of the lining of the uterus) might increase the chance of finding cancer cells in the fluid around the organs in your belly (positive peritoneal cytology). Endometrial cancer is common, and while most cases are found early, some patients experience recurrence. Researchers want to see if positive peritoneal cytology, which has been linked to worse outcomes, is more common when a V-care® intrauterine manipulator is used compared to a sponge stick during surgery. You may be able to join if you are 18 or older, have been diagnosed with endometrial cancer by biopsy, are planning standard surgery for early-stage endometrial cancer, and do not have signs of widespread cancer in your belly. The study will measure positive peritoneal cytology after 2 years.

Study design
This is an interventional study planning to enroll 350 women. It compares two surgical tools used during endometrial cancer surgery.
What's involved
Patients will undergo standard surgical staging for endometrial cancer, using either a V-care uterine manipulator or a sponge stick.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome, conversion of positive peritoneal cytology, will be measured at 2 years.

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NCT04570553

Use of an Intrauterine Manipulator and Its Correlation with Positive Peritoneal Cytology in Early Stage Endometrial Cancers

Recruiting
NAAges 18+InterventionalDiagnostic
WellSpan Health
~350 participants
Updated 2025-03-28 on ClinicalTrials.gov
What's tested:surgical staging

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Conversion of positive peritoneal cytology
Measured over 2 years
Endometrial Cancer
1 sites across 1 states
Pennsylvania1
  • Eav Lim, DO · PRINCIPAL_INVESTIGATOR · WellSpan Health

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Eligibility criteria

Inclusion

Subjects age 18 or older able to give informed consent
Biopsy diagnosed endometrial cancer (including endometrioid, serous, mucinous and clear cell histologies)
Planned standard of care surgical management of early stage endometrial cancer
No clinical evidence of disseminated intraperitoneal disease

Exclusion

Final pathology does not reflect diagnosis of endometrial cancer (including endometrioid, serous, mucinous, and clear cell histology)
Evidence of disseminated intraperitoneal disease
Subject is not a surgical candidate
Subject elects for fertility sparing or non-operative management
Subject is unable to provide informed consent
  • Conversion of positive peritoneal cytology2 years

    Intraoperative conversion rate from negative to positive peritoneal cytology will be assessed in each arm