Phase II Evaluation of Robotic-assisted Laparoscopic Extended Pelvic Lymph Node Dissection for Transitional Cell Carcinoma of the Bladder
Research has shown that the more lymph nodes removed as part of a radical cystectomy
(bladder removal) for invasive bladder cancer, the better. However, the number of lymph
nodes removed varies from person to person. The standard surgical techniques such as
robot-assisted procedures are new, and researchers want to be able to more reliably tell if
the specific number of lymph nodes removed is enough to be considered a "complete" removal.
In this study, researchers will remove the required lymph nodes using a standard
robotic-assisted procedure, and then remove any additional lymph nodes that remain and need
to be removed, using a wider ("open") incision in the abdomen. This open technique is also
being done for standard of care. It is needed in order to complete the "urinary diversion"
part of the surgery (a procedure of surgically making way for urine to pass out of the body
so that it does not go through the bladder).
The main goal of the study is to see if the robotic-assisted procedure removes all of the
required lymph nodes. The open technique will allow researchers to evaluate how many lymph
nodes were left behind after robotic-assisted removal.
It is possible that the machine may have problems and not be available for use on the
scheduled day of surgery. If that happens, you will have the option to reschedule surgery
or have standard open surgery. It is also possible that the machine could have problems
during your surgery. If that happens, your doctor will continue with standard open surgery.
Your study doctor will discuss these possible situations with you.
You will be asked to sign a separate consent form for these surgical procedures, which will
describe the procedures and their risks in more detail.
You will be asked to fill out a brief pain survey once a week for 7 weeks after surgery. The
survey will take about 5 minutes to complete. You will also be given a diary to record your
daily pain medication use. It will also take about 5 minutes to complete. You will continue
to complete the questionnaire once a week and to fill out the diary daily for 6 weeks.
You will visit the clinic 6-12 weeks after surgery for an end-of-study visit. You will have
a chest x-ray. Your pain medication use and pain level surveys will be collected. After this
visit, you will be off-study.
This is an investigational study. The robotic-assisted bladder removal is FDA approved for
this purpose. Up to 60 patients will be enrolled in this study. All will be enrolled at The
University of Texas (UT) MD Anderson Cancer Center (MDACC).
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Median Yield of Robot Assisted and Second Look Open Pelvic Lymph Node Dissection to Compare the Lymph Node Yield Achieved
The median yield (the lymph node count) allows for comparison of how many lymph nodes are left behind after robotic-assisted removal and are then found after a wider incision is made. Specifically a robot-assisted laparoscopic extended pelvic lymph node dissection (RA-PLND) is compared to a second-look open lymph node dissection (O-PLND) among participants undergoing radical cystectomy for urothelial carcinoma of the bladder. The median yield lymph nodes illustrate the adequacy of extended pelvic lymph node dissection using a robotic-assisted technique, i.e. whether the robotic-assisted laparoscopic radical cystectomy yields a sufficient number of lymph nodes to be oncologically equivalent to the open procedure.
3 months including surgery and post-operative period.
John W. Davis, MD
UT MD Anderson Cancer Center
United States: Institutional Review Board
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