MAN-U: Uterine Manipulation During Minimally Invasive Surgery for Early Stage Endometrial Cancer
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Surgery With UM (Arm MAN UA) Subjects that undergo a MIS approach with a uterine manipulator (experimental arm) |
Device: Surgery with UM
The experimental group will have MIS with the placement of a uterine manipulator
|
| Active Comparator: Surgery Without UM (Arm Control) Subjects that undergo a MIS approach without a uterine manipulator (control arm) |
Device: Surgery without UM
The control group will have MIS without the placement of a uterine manipulator
|
Outcome Measures
Primary Outcome Measures
- Positive peritoneal cytology (PC) [Immediately after uterine manipulator placement in the manipulator group or prior to the initiation of the hysterectomy procedure in the non-manipulator group]
Positive PC is defined as the presence of malignant cells in the peritoneal cytology specimen.
Secondary Outcome Measures
- Post-operative positive PC [Immediately after closure of the vaginal cuff]
Positive PC is defined as the presence of malignant cells in the peritoneal cytology specimen.
- Lymphovascular space invasion (LVSI) [During surgery]
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.
- Percentage of myometrial invasion (MI) [During surgery]
Defined as the % of invasion into the myometrium from the endomyometrial junction
- Extent of lymph node metastases [During surgery]
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.
- Operative time [1 day]
Defined as time from start of operation to closure of skin in minutes as documented in the electronic medical record
- Surgical morbidity [Intra-operative and up to 30 days post-surgery]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
A subject will be considered eligible for inclusion in this study if all the following criteria are met:
-
Patient must be greater than or equal to 18 years old.
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Suspected clinically early stage endometrial cancer of any histology (endometrioid, mixed, serous, clear-cell, carcinosarcomas, mucinous)
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Pre-operative imaging not suggestive of extra-uterine disease, if obtained pre-operatively.
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CA 125 testing is optional but, if obtained, must be within lab normal values. 5. ECOG performance status 0-2 (see appendix 1).
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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:
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Planned laparotomic hysterectomy
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On progesterone therapy to treat their endometrial cancer
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Any prior pelvic irradiation
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cleveland Clinic | Cleveland | Ohio | United States | 44195 |
| 2 | Baylor College of Medicine- McNair Campus | Houston | Texas | United States | 77030 |
| 3 | Baylor College of Medicine | Houston | Texas | United States | 77030 |
| 4 | Ben Taub General Hospital | Houston | Texas | United States | 77030 |
| 5 | Harris Health System - Smith Clinic | Houston | Texas | United States | 77054 |
Sponsors and Collaborators
- Anthony Costales, MD
- The Cleveland Clinic
Investigators
- Principal Investigator: Anthony Costales, MD, Baylor College of Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- H-46373