Robotic-Assisted Laparoscopic Extended Pelvic Lymph Node Dissection for Transitional Cell Carcinoma of the Bladder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00963859
First received: August 19, 2009
Last updated: April 10, 2013
Last verified: April 2013

August 19, 2009
April 10, 2013
October 2007
June 2011   (final data collection date for primary outcome measure)
  • Median Yield of Robot Assisted and Second Look Open Pelvic Lymph Node Dissection to Compare the Lymph Node Yield Achieved [ Time Frame: 3 months including surgery and post-operative period. ] [ Designated as safety issue: No ]
    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.
  • Overall Percentage Median Yield [ Time Frame: 3 months including surgery and post-operative period. ] [ Designated as safety issue: No ]
    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 illustrates the adequacy of extended pelvic lymph node dissection using a robotic-assisted technique.
Number of lymph nodes detected by robotic surgery divided by the total number of lymph nodes detected by robotic surgery or second surgery [ Time Frame: 3 months including surgery and post-operative period. ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00963859 on ClinicalTrials.gov Archive Site
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Robotic-Assisted Laparoscopic Extended Pelvic Lymph Node Dissection for Transitional Cell Carcinoma of the Bladder
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).

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Bladder Cancer
Procedure: Robotic-assisted laparoscopic surgery
During radical cystectomy, robotic-assisted technique used to perform cystectomy and pelvic lymph node dissections. Each patient will undergo a second-look open lymph node dissection once the incision is made at the end for the urinary diversion.
Experimental: Robotic-assisted laparoscopic surgery
Robotic-assisted laparoscopic extended pelvic lymph node dissection
Intervention: Procedure: Robotic-assisted laparoscopic surgery
Davis JW, Gaston K, Anderson R, Dinney CP, Grossman HB, Munsell MF, Kamat AM. Robot assisted extended pelvic lymphadenectomy at radical cystectomy: lymph node yield compared with second look open dissection. J Urol. 2011 Jan;185(1):79-83. doi: 10.1016/j.juro.2010.09.031. Epub 2010 Nov 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
11
June 2011
June 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Patients who are eligible for a radical cystectomy and who, in the opinion of the treating MDACC physician, are candidates for a robotic-assisted laparoscopic technique for management of the bladder and lymph nodes.
  2. Diagnosis of transitional cell carcinoma of the bladder.
  3. Medical fitness for open radical cystectomy by consensus of MDACC urology and anesthesia faculty (medicine/cardiology clearance by common best practice criteria).
  4. Staging inclusion by cystoscopic biopsy and bimanual examination under anesthesia: carcinoma in-situ, T1, T2.

Exclusion Criteria:

  1. Prior pelvic radiation.
  2. Morbid obesity, i.e., body mass index (BMI)> 35.
  3. Metastatic disease, bulky disease--T3a/b, prostatic stromal invasion.
  4. Non-transitional cell histology.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00963859
2007-0441
No
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
Not Provided
Study Chair: John W. Davis, MD UT MD Anderson Cancer Center
M.D. Anderson Cancer Center
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP