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

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 UT M. D. Anderson Cancer Center (MDACC).

Intervention(s) in this Clinical Trial

• 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.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Robotic-assisted laparoscopic surgery
  • Robotic-assisted laparoscopic extended pelvic lymph node dissection

Primary Measures

• 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.
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: M.D. Anderson Cancer Center Other

Overall Clinical Trial Officials and Contacts

John W. Davis, MD Study Chair UT MD Anderson Cancer Center  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00963859

Study ID Number: 2007-0441

ClinicalTrials.gov Identifier: NCT00963859

Health Authority: United States: Institutional Review Board

UT MD Anderson Cancer Center website