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

Completed · Phase 2

Conditions studied: Bladder Cancer

In brief

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.

Key facts

Study ID

NCT00963859

Run by

M.D. Anderson Cancer Center

People needed

11

Starts

2007-10-01

Expected to finish

2011-06-01

Last updated by the study team

2013-05-21

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Diagnosis of transitional cell carcinoma of the bladder.
• Medical fitness for open radical cystectomy by consensus of MDACC urology and anesthesia faculty (medicine/cardiology clearance by common best practice criteria).
• Staging inclusion by cystoscopic biopsy and bimanual examination under anesthesia: carcinoma in-situ, T1, T2.

You may not qualify if…

• Prior pelvic radiation.
• Morbid obesity, i.e., body mass index (BMI)> 35.
• Metastatic disease, bulky disease--T3a/b, prostatic stromal invasion.
• Non-transitional cell histology.

Where it is running

• UT MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.