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

NCT00963859 | Completed Phase 2 Results

• 1 other identifier: 2007-0441
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Bladder Cancer

Keywords

Robotic-assisted laparoscopic surgery; Extended pelvic lymph node dissection; RA-PLND; Second-look open lymph node dissection; O-PLND; Radical Cystectomy; Urinary diversion; Bladder

Outcome Measures

Primary Outcomes (2)

• 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.

• 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.

Study Arms (1)

Robotic-assisted laparoscopic surgery

EXPERIMENTAL

Robotic-assisted laparoscopic extended pelvic lymph node dissection

Procedure: Robotic-assisted laparoscopic surgery

Interventions

Robotic-assisted laparoscopic surgery PROCEDURE

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.

Robotic-assisted laparoscopic surgery

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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).

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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• 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.juro.2010.09.031. Epub 2010 Nov 12.

  PMID: 21074799 RESULT

Related Links

• UT MD Anderson Cancer Center website

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: John W. Davis, MD / Assistant Professor
• Organization: The University of Texas (UT) MD Anderson Cancer Center

CR_Study_Registration@mdanderson.org

Study Officials

• John W. Davis, MD

  UT MD Anderson Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2009
• First Posted: August 24, 2009
• Study Start: October 1, 2007
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: May 21, 2013
• Results First Posted: May 21, 2013

Record last verified: 2013-04

Locations

US (1)