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

Trial Summary

What is the purpose of this trial?

This trial investigates whether using the Vcare® tool during surgery affects the presence of cancer cells in patients with early-stage endometrial cancer. The tool helps surgeons by stabilizing the uterus, aiming for more efficient and safe surgeries.

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 data supports the effectiveness of the treatment Vcare® intrauterine manipulator for endometrial cancer?

Research shows that using an intrauterine manipulator during surgery for endometrial cancer can help improve surgical outcomes by allowing better access and visibility during the procedure. This can lead to more accurate removal of cancerous tissue and potentially better long-term results for patients. ^{1 2 3 4 5}

Is intrauterine manipulation for endometrial cancer generally safe for humans?

Surgical staging, which includes procedures like intrauterine manipulation, is generally considered safe when performed by trained specialists. Studies have shown that minimally invasive surgery for endometrial cancer is relatively safe, and surgical staging is a standard part of treatment, indicating its safety in clinical practice. ^{4 6 7 8 9}

How does intrauterine manipulation differ from other treatments for endometrial cancer?

Intrauterine manipulation is unique because it involves using a device inside the uterus during surgery to help with the removal of cancerous tissue, which may improve surgical outcomes. This approach is different from other treatments that do not use such a device and focuses on enhancing the precision and effectiveness of the surgical procedure. ^{1 2 10 11 12}

Research Team

Eav Lim, DO

Principal Investigator

WellSpan Health

Eligibility Criteria

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 am 18 or older and can give my consent.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Effects of uterine manipulation on surgical outcomes in laparoscopic management of endometrial cancer: a prospective randomized clinical trial. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Intrauterine manipulator during hysterectomy for endometrial cancer: a systematic review and meta-analysis of oncologic outcomes. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Role of laparoscopic surgery in the management of endometrial cancer. [2019]

4. Germany pubmed.ncbi.nlm.nih.gov

[Endometrial cancer -- suggestions for the update of the guidelines]. [2008]

5. United States pubmed.ncbi.nlm.nih.gov

Surgical staging endometrial cancer. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Current issues in the management of endometrial cancer. [2013]

7. England pubmed.ncbi.nlm.nih.gov

Outcomes of minimally invasive surgery for patients with endometrial carcinoma involving the cervix. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Ovarian preservation for premenopausal women with early-stage endometrial cancer: a Chinese retrospective study. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Endometrial cancer: is surgical staging necessary? [2019]

10. Germany pubmed.ncbi.nlm.nih.gov

Iatrogenic transtubal spill of endometrial cancer: risk or myth. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Intrauterine Manipulator Use During Minimally Invasive Hysterectomy and Risk of Lymphovascular Space Invasion in Endometrial Cancer. [2020]

12. United States pubmed.ncbi.nlm.nih.gov

Total laparoscopic hysterectomy in early-stage endometrial cancer using an intrauterine manipulator: is it a bias for frozen section analysis? Case-control study. [2011]