Uterine Manipulation in Surgery for Endometrial Cancer

(MAN-U Trial)

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen by Anthony Costales, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Anthony Costales, MD

Must not be taking: Progesterone

Disqualifiers: Laparotomic hysterectomy, Pelvic irradiation, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This is a prospective, multi-center, randomized non-inferiority phase III study to evaluate if patients undergoing a minimally invasive surgery for early stage uterine cancer have cancer cells in the fluid that is obtained at the time of their surgery when a uterine manipulator is placed versus patients who do not have a uterine manipulator placed.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are on progesterone therapy to treat endometrial cancer, you cannot participate in the trial.

What data supports the effectiveness of this treatment for endometrial cancer surgery?

The research indicates that there is limited evidence on the effectiveness of using a uterine manipulator in endometrial cancer surgery, with concerns about potential tumor spread during surgery. Decisions on its use are often based on surgeon preference and experience rather than strong evidence.

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Is the use of a uterine manipulator generally safe in surgery for endometrial cancer?

The use of a uterine manipulator in minimally invasive surgery for endometrial cancer is generally considered fairly safe, but its application should be tailored to the size and extent of the tumor. Some concerns exist about potential tumor spread during surgery, but recent studies highlight its safety in early-stage cases.

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How does the use of a uterine manipulator in surgery for endometrial cancer differ from other treatments?

The use of a uterine manipulator (UM) in surgery for endometrial cancer is unique because it is a tool used during minimally invasive surgery to improve surgical ergonomics, but its safety and impact on cancer spread are debated. Unlike other treatments, the decision to use a UM is often based on the surgeon's experience and preference, as there is limited evidence on its effect on cancer outcomes.

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Eligibility Criteria

This trial is for adults over 18 with suspected early stage endometrial cancer, who are fit enough for minimally invasive surgery (MIS) and have no signs of cancer spread outside the uterus. They must be able to follow the study's procedures and not have had pelvic radiation or progesterone therapy for their cancer.

Inclusion Criteria

I am 18 years old or older.

CA 125 testing is optional but, if obtained, must be within lab normal values

I can take care of myself and am up and about more than half of the day.

Exclusion Criteria

I have had radiation therapy to my pelvic area before.

I am scheduled for a hysterectomy through an abdominal incision.

I am on progesterone therapy for my endometrial cancer.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo minimally invasive surgery for early stage uterine cancer with or without a uterine manipulator

1 day

1 visit (in-person)

Immediate Post-operative

Assessment of positive peritoneal cytology and other surgical outcomes immediately after surgery

Immediately post-surgery

Follow-up

Participants are monitored for surgical morbidity and other outcomes up to 30 days post-surgery

30 days

Participant Groups

The study compares outcomes in patients undergoing MIS for early stage uterine cancer using a uterine manipulator (UM) versus those without UM. It aims to see if there's a difference in the presence of cancer cells in surgical fluid between these two methods.

Group I: Surgery With UM (Arm MAN UA) Experimental Treatment 1 Intervention

Subjects that undergo a MIS approach with a uterine manipulator (experimental arm)

Group II: Surgery Without UM (Arm Control) Active Control 1 Intervention

Subjects that undergo a MIS approach without a uterine manipulator (control arm)

Surgery without UM is already approved in European Union, United States for the following indications:

🇪🇺 Approved in European Union as Minimally Invasive Surgery for:

• Early-stage endometrial cancer

🇺🇸 Approved in United States as Minimally Invasive Surgery for:

• Early-stage endometrial cancer

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Ben Taub General Hospital Houston, TX

Baylor College of Medicine Houston, TX

Harris Health System - Smith Clinic Houston, TX

Baylor College of Medicine- McNair Campus Houston, TX

Who Is Running the Clinical Trial?

Anthony Costales, MD Lead Sponsor

The Cleveland Clinic Collaborator

References

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

Use of uterine manipulator in endometrial cancer: A French survey from Francogyn group. [2022] Since the LACC study in 2018, the use of the uterine manipulator (UM) has been questioned in Oncological surgery. Nowadays, there are few data on UM use in patients eligible for minimally invasive surgery for endometrial cancer. Our objective was to evaluate the practices and modalities of UM use by French onco-gynecologic surgeons in the management of endometrial cancer.

2. England pubmed.ncbi.nlm.nih.gov

The effects of uterine manipulators in minimally invasive hysterectomy for endometrial cancer: A systematic review and meta-analysis. [2020] Minimally invasive surgery has achieved great success in the surgical treatment of many kinds of cancer. This study aimed to systematically review the available evidence evaluating the effects of the use of uterine manipulators in minimally hysterectomies for endometrial cancer patients.

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

Impact of uterine manipulator on oncological outcome in endometrial cancer surgery. [2021] There are limited data available to indicate whether oncological outcomes might be influenced by the uterine manipulator, which is used at the time of hysterectomy for minimally invasive surgery in patients with endometrial cancer. The current evidence derives from retrospective studies with limited sample sizes. Without substantial evidence to support its use, surgeons are required to make decisions about its use based only on their personal choice and surgical experience.

4. France pubmed.ncbi.nlm.nih.gov

Use of uterine manipulator and uterine perforation in minimally invasive endometrial cancer surgery. [2023] Safety of the uterine manipulator (UM) within endometrial cancer (EC) surgery is being questioned. Its use might be one of the issues for potential tumor dissemination during the procedure, especially in the case of uterine perforation (UP). No prospective data on this surgical complication, nor on the oncological consequences exist. The aim of this study was to assess the rate of UP while using UM when performing surgery for EC and the impact of UP on the choice of adjuvant treatment.

5. England pubmed.ncbi.nlm.nih.gov

Does the use of a uterine manipulator in robotic surgery for early-stage endometrial cancer affect oncological outcomes? [2022] To investigate the impact of the use of a uterine manipulator in robot-assisted surgery for early-stage endometrial cancer on oncological outcome.

6. China pubmed.ncbi.nlm.nih.gov

Role of uterine manipulator during laparoscopic endometrial cancer treatment. [2022] Endometrial cancer (EC) is the most frequent gynecologic malignancy with 61,000 new cases diagnosed per year in the USA. Gynecologic Oncology Group (GOG) LAP2 randomized study demonstrated a superimposable 5-year overall survival between laparotomic and laparoscopic approaches in EC treatment. In this context the uterine manipulator (UM) represents a valuable tool in order to increase the ergonomics of surgical gesture during a laparoscopic total hysterectomy. Despite the proven safety of the minimally invasive approach in EC treatment, neither the indication whether to use or not, nor the recommendation concerning a specific type of UM are provided by international guidelines. This narrative review aims to collect all the main findings in the literature about UM use to investigate its safety in EC patients. Based on the analysis of the literature research, the main results were categorized into two manipulator-related problems: the iatrogenic LVSI, and the retrograde tumor spillage. LVSI is defined as the presence of tumor cells within an endothelium-lined space. An electronic search was performed using the following keywords: 'uterine manipulator', and 'endometrial cancer'. The electronic database search provided a total of 93 studies. Of whom, 12 case reports, 5 studies not in English language, and 65 works not fitting the review scope were excluded from the analysis. Eleven studies were considered eligible for the purpose of the study. The most recent studies have highlighted the safety of the uterine manipulator in the early-stage EC laparoscopic treatment. All types of manipulators are considered to be fairly safe but its application should be tailored according to tumor dimension and grade of myometrial infiltration.