Uterine Manipulation During Minimally Invasive Surgery for Early Stage Endometrial Cancer

ENDOMETRIAL CANCER Clinical Trial

— MAN-U  

Official title:

Uterine Manipulation During Minimally Invasive Surgery for Early Stage Endometrial Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04586959
• Other study ID #: H-46373
• Status: Recruiting
• Phase: N/A
• Start date: May 21, 2021
• Est. completion date: October 2025

Study information

• Verified date: August 2023
• Source: Baylor College of Medicine
• Contact: Anthony Costales, MD
• Phone: 713-798-3495
• Email: costales[@]bcm.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

In most cases, patients who have early stage endometrial cancer undergo a surgery to remove the uterus, cervix, tubes, ovaries, and occasionally lymph nodes. This is usually done through a minimally invasive (not a large incision) surgery. To accomplish this, the uterus needs to be manipulated (moved around) to help the surgeon complete your surgery. This is usually done with a device called a uterine manipulator and the majority of surgeons use this device in any patient undergoing a minimally invasive hysterectomy (removal of the uterus and cervix).

Even though the majority of surgeons use a manipulator, there are some surgeons who believe there is a possibility that cancer cells inside the uterus can be spilled into the abdomen through the fallopian tubes. This may cause a higher risk of spreading the cancer and or of the cancer coming back.

Currently, there are very limited research studies directly looking at whether the uterine manipulator may cause these cells to appear in the abdomen.

The purpose of this study is to see 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.

A computer program will randomly assign the subjects to one of two groups. One group will have minimally invasive surgery with the use of a uterine manipulator and the other group will have minimally invasive surgery without the use of a uterine manipulator.

Researchers will use the information from this study to decide how best to take care of patients undergoing minimally invasive surgery for uterine cancer.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 278
• Est. completion date: October 2025
• Est. primary completion date: July 28, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

A subject will be considered eligible for inclusion in this study if all the following criteria are met:

1. Patient must be greater than or equal to 18 years old.

2. Suspected clinically early stage endometrial cancer of any histology (endometrioid, mixed, serous, clear-cell, carcinosarcomas, mucinous)

3. Pre-operative imaging not suggestive of extra-uterine disease, if obtained pre-operatively.

4. CA 125 testing is optional but, if obtained, must be within lab normal values. 5. ECOG performance status 0-2 (see appendix 1).

6. Signed informed consent and ability to comply with follow-up. 7. Per the opinion of the treating investigator, the patient must be a suitable candidate for the MIS surgical procedure.

Exclusion Criteria:

A subject must not have any of the following criteria:

1. Planned laparotomic hysterectomy

2. On progesterone therapy to treat their endometrial cancer

3. Any prior pelvic irradiation

Related Conditions & MeSH terms

• ENDOMETRIAL CANCER
• Endometrial Neoplasms

Intervention

Device:
• Surgery with UM
The experimental group will have MIS with the placement of a uterine manipulator
• Surgery without UM
The control group will have MIS without the placement of a uterine manipulator

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio
United States	Baylor College of Medicine	Houston	Texas
United States	Baylor College of Medicine- McNair Campus	Houston	Texas
United States	Ben Taub General Hospital	Houston	Texas
United States	Harris Health System - Smith Clinic	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Anthony Costales, MD	The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive peritoneal cytology (PC)	Positive PC is defined as the presence of malignant cells in the peritoneal cytology specimen.	Immediately after uterine manipulator placement in the manipulator group or prior to the initiation of the hysterectomy procedure in the non-manipulator group
Secondary	Post-operative positive PC	Positive PC is defined as the presence of malignant cells in the peritoneal cytology specimen.	Immediately after closure of the vaginal cuff
Secondary	Lymphovascular space invasion (LVSI)	LVSI is defined as the presence of tumor cells within a definite endothelial-lined space (lymphatics or blood vessels) at the advancing edge of the tumor as it invades the myometrium, within an endometrial polyp, or within the endometrial stroma.	During surgery
Secondary	Percentage of myometrial invasion (MI)	Defined as the % of invasion into the myometrium from the endomyometrial junction	During surgery
Secondary	Extent of lymph node metastases	Defined as presence of isolated tumor cells (ITC - <0.2 mm), or micrometastasis (mm - 0.2 - 2 mm), or macrometastasis (MM - > 2 mm), whichever is greater.	During surgery
Secondary	Operative time	Defined as time from start of operation to closure of skin in minutes as documented in the electronic medical record	1 day
Secondary	Surgical morbidity	Surgical morbidity (CTCAE v5.0) grade 3 and higher, or any grade of the following adverse events: colonic fistula, colonic perforation, enterovesical fistula, gastrointestinal fistula, ileus, intra-abdominal hemorrhage, rectal fistula, rectal perforation, small intestinal perforation, abdominal infection, pelvic infection, vaginal infection, intra-operative arterial injury, venous injury, intra-operative gastrointestinal injury, intra-operative hemorrhage, intra-operative neurological injury, intra-operative urinary injury, and post-operative hemorrhage.	Intra-operative and up to 30 days post-surgery