Brief Title
Uterine Manipulation During Minimally Invasive Surgery for Early Stage Endometrial Cancer
Official Title
Uterine Manipulation During Minimally Invasive Surgery for Early Stage Endometrial Cancer
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.
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 Type
Interventional
Primary Outcome
Positive peritoneal cytology (PC)
Secondary Outcome
Post-operative positive PC
Condition
ENDOMETRIAL CANCER
Intervention
Surgery with UM
Study Arms / Comparison Groups
Surgery With UM (Arm MAN UA)
Description: Subjects that undergo a MIS approach with a uterine manipulator (experimental arm)
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
278
Start Date
May 21, 2021
Completion Date
October 2025
Primary Completion Date
July 28, 2023
Eligibility Criteria
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
Gender
Female
Ages
18 Years - 90 Years
Accepts Healthy Volunteers
No
Contacts
Anthony Costales, MD, 713-798-3495, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT04586959
Organization ID
H-46373
Responsible Party
Sponsor-Investigator
Study Sponsor
Anthony Costales, MD
Collaborators
The Cleveland Clinic
Study Sponsor
Anthony Costales, MD, Principal Investigator, Baylor College of Medicine
Verification Date
February 2023