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

March 24, 2025 updated by: Eav Lim, WellSpan Health
This study aims to answer whether use of a Vcare® intrauterine manipulator leads to an increased incidence of positive peritoneal cytology in patients undergoing surgical management of early stage (FIGO stage I/II) endometrial cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Endometrial cancer is the sixth most common cancer diagnosed in women worldwide and the leading gynecologic cancer in developed countries, accounting for nearly 50% of all newly diagnosed gynecologic cancers in the United States . The majority of endometrial cancers are diagnosed at an early stage which portends a favorable prognosis. Despite early diagnosis and generally favorable prognosis in these cancers, approximately 13% of patients will experience recurrence . Most recurrences occur in patients with known high-risk pathologic features, however approximately 3% of recurrences occur in patients with no high-risk pathology features . While well-defined pathologic factors such as age, tumor grade, and depth of invasion have been described for high-risk of recurrence, predicting recurrence in low-risk patients has been an ongoing challenge in the management of early stage endometrial cancers

One potential contribution to recurrence in low-risk endometrial cancers may be the presence of positively malignant peritoneal cytology. Positive peritoneal cytology (PPC) has been an ongoing topic of debate regarding its significance and optimal management in early stage endometrial cancers. Creasman and Rutledge initially described the prognostic value of peritoneal cytology in 1971 by linking PPC with worse survival at 4 years . Since then multiple studies have sought to address the significance of peritoneal cytology in endometrial cancer, many with conflicting results. Studies by Kasamatsu et al, Fadare et al, Lurain et al and Scott et al found that PPC is not a significant prognostic factor for disease recurrence or survival . Contrary to these data however studies by Lee et al, Garg et al, and Seagle et al have shown a positive correlation with PPC as both a prognostic factor and survival . Despite these conflicting data directing the significance of PPC, it remains an important contributing factor in the management and prognosis of endometrial cancer. Although peritoneal cytology was removed from FIGO staging in 2009, NCCN guidelines continue to recommend the collection of peritoneal cytology in order to further elucidate the impact of PPC, with some authors calling for the reinstatement of peritoneal cytology in endometrial cancer staging .

In addition to the effects of pathological factors and peritoneal cytology on recurrence risk, recent studies in other gynecologic cancers have shown how different approaches in surgical management play a key role in overall disease prognosis and outcomes. The LACC trial, published in 2018, demonstrated the effects of differing surgical technique on outcomes by showing that patients undergoing minimally invasive surgery for management of cervical cancers fared worse in locoregional recurrence, disease-free survival and overall survival than patients undergoing traditional laparotomy. This study highlights the impact of surgical methodology on the prognosis and outcomes of oncologic surgery.

Similar to the management of cervical cancers, over the last two decades laparoscopic surgery and staging has become the mainstay of management for women with uterine cancers. The traditional approach of laparotomy with hysterectomy, bilateral salpingo-oophorectomy, pelvic and para-aortic lymphadenectomy has come to be effectively replaced with the minimally invasive, laparoscopic approach which affords an equally efficacious surgery with shorter recovery and fewer complications . In order to perform more efficient and safe surgeries, intrauterine manipulators have been employed in laparoscopic hysterectomy. Since their introduction into gynecologic oncology surgery questions have risen regarding the possibility of increased risk of tumor dissemination with usage of intrauterine manipulators. The mechanisms of this have been theorized to include retrograde dissemination via the fallopian tubes into the peritoneal cavity as well as increased lymphovascular space invasion . Multiple studies have focused on the question of retrograde dissemination via the fallopian tubes with conflicting results. A retrospective study by Sonoda et el found that when low-risk endometrial cancer was managed with laparoscopic assisted vaginal hysterectomy (LAVH) using an inflatable intrauterine manipulator, it was associated with increased incidence of positive peritoneal cytology compared to the control population (10.3% versus 2.8%). Lim et al prospectively evaluated the effect of uterine manipulator use on peritoneal cytology in laparoscopic hysterectomy using a RUMI manipulator and KOH colpotomizer and found that 4.3% of patients in their study were upstaged due to PPC following usage of a uterine manipulator . However, contrary to this, two prospective studies found that usage of a uterine manipulator did not increase the incidence of malignant peritoneal cytology in patients undergoing laparoscopic staging. A prospective study by Eltabakh et al evaluated conversion from negative to PPC immediately following insertion of a Pelosi uterine manipulator in 42 patients. Based on their results that demonstrated no patients converted to PPC, they concluded that intrauterine manipulators do not increase the incidence of PPC. Additionally, Lee et al published results of a randomized parallel trial of 110 patients undergoing laparoscopic surgery and staging for stage I endometrial cancer either with or without a uterine manipulator which showed no significant difference in the rate of positive cytology in either group.

This study will be a randomized control trial in which patients will be randomized into two study arms following informed consent: a control arm utilizing a non-invasive sponge stick (Foerster ring forceps containing a raytec sponge (Vistec Covidien Health, Mansfield, MA)) placed in the vagina for surgical assistance or a Vcare® intrauterine manipulator (ConMed Endosurgery, Utica, NY). Patients randomized to the Vcare® group will have the Vcare® placed in the usual fashion under direct visualization following entrance into the abdomen. Cytology washings will be obtained following entrance into the peritoneal cavity. Washings will be obtained by washing approximately 150cc of normal saline over the bilateral paracolic gutters, uterine fundus, and anterior and posterior cul de sacs. Fifty milliliters of fluid will then be aspirated for cytology collection. Cytology washings will then be obtained again prior to colpotomy. Patients will undergo total laparoscopic hysterectomy or robotic assisted total laparoscopic hysterectomy. Peritoneal washings obtained during surgery will be processed and undergo pathological examination. Covariate data including age, BMI, history of previous tubal ligation, FIGO stage, histologic type, histologic grade, lymphovascular space invasion, and gross evidence of tumor spillage will also be obtained.

Study Type

Interventional

Enrollment (Estimated)

350

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Pennsylvania
      • York, Pennsylvania, United States, 17403
        • Recruiting
        • WellSpan Health
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: V-care uterine manipulator
Patients in the V-care uterine manipulator arm will undergo standard staging surgery utilizing a V-care uterine manipulator in the standard fashion
Procedure: surgical staging
Patients will undergo standard surgical staging for endometrial cancer utilizing either a V-care uterine manipulator or sponge stick
Active Comparator: Sponge stick
Patients in the sponge stick arm will undergo standard staging surgery utilizing a non-invasive sponge stick for cervical delineation.
Procedure: surgical staging
Patients will undergo standard surgical staging for endometrial cancer utilizing either a V-care uterine manipulator or sponge stick

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Conversion of positive peritoneal cytology
Time Frame: 2 years
Intraoperative conversion rate from negative to positive peritoneal cytology will be assessed in each arm
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence rate
Time Frame: 2 years
Endometrial cancer rates at 2 years from surgery will be assessed
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

WellSpan Health

Investigators

  • Principal Investigator: Eav Lim, DO, WellSpan Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2020

Primary Completion (Estimated)

April 30, 2026

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

September 25, 2020

First Submitted That Met QC Criteria

September 25, 2020

First Posted (Actual)

September 30, 2020

Study Record Updates

Last Update Posted (Actual)

March 28, 2025

Last Update Submitted That Met QC Criteria

March 24, 2025

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1627644

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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