Status:
COMPLETED
Robotic-Assisted Laparoscopic Extended Pelvic Lymph Node Dissection for Transitional Cell Carcinoma of the Bladder
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Bladder Cancer
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
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 havin...
Detailed Description
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 re...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00963859
Start Date
October 1 2007
End Date
June 1 2011
Last Update
May 21 2013
Active Locations (1)
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1
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030