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
Verified date | April 2013 |
Source | M.D. Anderson Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 11 |
Est. completion date | June 2011 |
Est. primary completion date | June 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
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. |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | UT MD Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center |
United States,
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.j — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Median Yield of Robot Assisted and Second Look Open Pelvic Lymph Node Dissection to Compare the Lymph Node Yield Achieved | 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. | 3 months including surgery and post-operative period. | No |
Primary | Overall Percentage Median Yield | 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. | 3 months including surgery and post-operative period. | No |
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