Phase 2
Completed N=11
Robotic-Assisted Laparoscopic Extended Pelvic Lymph Node Dissection for Transitional Cell Carcinoma of the Bladder
Source: ClinicalTrials.gov NCT00963859 ↗Enrolled (actual)
11
Serious AEs
9.1%
Results posted
May 2013
Primary outcomePrimary: Median Yield of Robot Assisted and Second Look Open Pelvic Lymph Node Dissection to Compare the Lymph Node Yield Achieved — 43; 4 Nodes (Node Yield)
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 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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Median Yield of Robot Assisted and Second Look Open Pelvic Lymph Node Dissection to Compare the Lymph Node Yield Achieved |
43; 4 | — |
| PRIMARY Overall Percentage Median Yield |
93; 7 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00963859). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.