Bladder Cancer Clinical Trial
Official title:
Phase II Evaluation of Robotic-assisted Laparoscopic Extended Pelvic Lymph Node Dissection for Transitional Cell Carcinoma of the Bladder
The goal of this clinical research study is to evaluate how many lymph nodes are left behind
after robotic-assisted removal and are then found after a wider incision is made, in
patients who are having their bladder removed for the treatment of bladder cancer.
The primary objective is to compare the lymph node yield achieved by performing a
robotic-assisted laparoscopic extended pelvic lymph node dissection (RA-PLND) compared to a
second-look open lymph node dissection (O-PLND) among patients undergoing radical cystectomy
for transitional cell carcinoma of the bladder.
The secondary objectives will be to collect prospective outcomes data related to the
performance of RA-PLND and robotic-assisted cystectomy (RA-C) including operative times,
estimated blood loss, transfusions, complications, return to diet, utilization of pain
medication, hospital length, return to regular activities.
Study Background:
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.
Follow-up:
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.
End-of-Study Visit:
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).
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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