Intrauterine Manipulation for Endometrial Cancer

Overseen By Eav Lim, DO

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: WellSpan Health

Disqualifiers: Disseminated disease, Non-surgical candidate, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Surgery duration

350 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how different surgical tools might affect the spread of endometrial cancer. It specifically compares two methods: a sponge stick and a V-care uterine manipulator, a device used inside the uterus during surgery. The researchers aim to determine if the V-care manipulator results in more cancer cells appearing in the abdomen. Women with a confirmed diagnosis of early-stage endometrial cancer who plan to undergo standard surgical treatment, known as surgical staging, may be suitable candidates.

As an unphased trial, this study provides a unique opportunity to enhance understanding of how surgical tools impact cancer spread.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Vcare® intrauterine manipulator is safe for use in surgical management of endometrial cancer?

Research has shown that the V-care uterine manipulator, used in surgeries for endometrial cancer, is generally safe. Studies indicate it does not increase the risk of cancer cells spreading into blood or lymph vessels, which supports its safety profile. One study found no significant connection between using the manipulator and patient survival, suggesting it doesn't worsen cancer outcomes. Although one study suggested worse results for some patients, the consensus is that these manipulators are quite safe. They should be used carefully, considering the size and depth of the tumor. Overall, the manipulator can be safely used in surgeries for endometrial cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative tools for surgical staging in endometrial cancer, potentially enhancing precision and safety. The sponge stick offers a non-invasive approach for cervical delineation, which might reduce surgical trauma compared to traditional methods. Meanwhile, the V-care uterine manipulator provides a controlled and consistent way to position the uterus during surgery, which could improve surgical accuracy and outcomes. These advancements aim to refine the surgical process, making it more efficient and potentially improving recovery for patients.

What evidence suggests that the Vcare® intrauterine manipulator is effective for endometrial cancer?

Research shows that the Vcare intrauterine manipulator aids surgeries, such as hysterectomies, for treating endometrial cancer by simplifying the procedure. Studies have found that using this tool does not significantly affect patients' cancer-free duration or overall survival. In this trial, participants will be divided into two groups: one will undergo surgery using the Vcare uterine manipulator, while the other will use a non-invasive sponge stick for cervical delineation. The trial explores whether the Vcare tool can improve the detection of cancer cells in a specific fluid sample during surgery, potentially impacting surgical outcomes for early-stage endometrial cancer. ^{1 2 6 7 8}

Who Is on the Research Team?

Eav Lim, DO

Principal Investigator

WellSpan Health

Are You a Good Fit for This Trial?

This trial is for adults over 18 with diagnosed endometrial cancer who are able to consent and are set for standard surgical treatment without signs of widespread disease in the abdomen. It's not for those whose final pathology isn't endometrial cancer, have spread of cancer within the abdomen, can't undergo surgery, or choose non-surgical management.

Inclusion Criteria

My cancer has not spread within my abdomen.

I am scheduled for surgery for early stage endometrial cancer.

I have been diagnosed with endometrial cancer through a biopsy.

Exclusion Criteria

I cannot undergo surgery for my condition.

I am unable to understand and give consent for treatment.

My cancer has spread within my abdomen.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo randomized control trial with either a sponge stick or V-care intrauterine manipulator during laparoscopic hysterectomy

Surgery duration

1 visit (in-person)

Follow-up

Participants are monitored for recurrence and conversion of positive peritoneal cytology

2 years

What Are the Treatments Tested in This Trial?

Interventions

• surgical staging
• Vcare® intrauterine manipulator

Trial Overview The study investigates if using a Vcare® intrauterine manipulator during surgery increases the chance of finding cancer cells in the abdominal fluid in early stage (FIGO I/II) endometrial cancer patients.

How Is the Trial Designed?

Group I: V-care uterine manipulator Experimental Treatment 1 Intervention

Patients in the V-care uterine manipulator arm will undergo standard staging surgery utilizing a V-care uterine manipulator in the standard fashion

Group II: Sponge stick Active Control 1 Intervention

Patients in the sponge stick arm will undergo standard staging surgery utilizing a non-invasive sponge stick for cervical delineation.

Who Is Running the Clinical Trial?

WellSpan Health

Lead Sponsor

Trials

32

Recruited

2,005,000+

Graham Brown, DO

Lead Sponsor

Trials

2

Recruited

630+

Published Research Related to This Trial

Surgical staging is now the standard treatment for women with endometrial cancer, and it has been shown to be safe when performed by specially trained surgeons.

Routine postoperative teletherapy is not cost-effective and does not improve survival rates, highlighting the need for careful preoperative assessment and the availability of advanced surgical options during the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endometrial cancer: is surgical staging necessary? Orr, JW., Roland, PY., Leichter, D., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7526862/

Intrauterine Manipulator Use During Minimally Invasive ... The effectiveness of using an intrauterine manipulator (IUM) during laparoscopic hysterectomy is well demonstrated. Nevertheless, some surgeons avoid using this ...

2. ajog.org ajog.org/article/S0002-9378(23)00610-5/fulltext

Intrauterine manipulator during hysterectomy for ... Intrauterine manipulator use during hysterectomy for endometrial cancer was neither significantly associated with recurrence-free and overall survival.

3. tcr.amegroups.org tcr.amegroups.org/article/view/41996/html

Role of uterine manipulator during laparoscopic endometrial ... The uterine manipulator (UM) represents a valuable tool in order to increase the ergonomics of surgical gesture during a laparoscopic total hysterectomy.

4. withpower.com withpower.com/trial/phase-endometrial-neoplasms-9-2020-0036c

Intrauterine Manipulation for Endometrial Cancer This trial investigates whether using the Vcare® tool during surgery affects the presence of cancer cells in patients with early-stage endometrial cancer.

5. sciencedirect.com sciencedirect.com/science/article/pii/S0002937823006105

Systematic Reviews Intrauterine manipulator during ... Intrauterine manipulator use during hysterectomy for endometrial cancer was neither significantly associated with recurrence-free and overall survival.

6. ajog.org ajog.org/article/S0002-9378(20)30744-4/fulltext

Impact of uterine manipulator on oncological outcome in ... In this study, the use of a uterine manipulator was associated with a worse oncological outcome in patients with uterus-confined endometrial ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8799210/

Role of uterine manipulator during laparoscopic ... All types of manipulators are considered to be fairly safe but its application should be tailored according to tumor dimension and grade of myometrial ...

8. oatext.com oatext.com/use-of-the-uterine-manipulator-in-minimally-invasive-surgery-for-endometrial-cancer-oncological-outcomes.php

Use of the uterine manipulator in minimally invasive ... Conclusion: Our results confirm that the uterine manipulator can be used safely during surgery for endometrial carcinoma. Key words. endometrial ...