Trial Outcomes & Findings for Robotic-Assisted Laparoscopic Extended Pelvic Lymph Node Dissection for Transitional Cell Carcinoma of the Bladder (NCT NCT00963859)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

11 participants

Primary outcome timeframe

3 months including surgery and post-operative period.

Results posted on

2013-05-21

Participant Flow

Recruitment Period: October 10, 2007 to December 07, 2009; All recruitment done in a medical clinic setting.

Participant milestones

Participant milestones
Measure	Robotic-assisted Laparoscopic Surgery Robotic-assisted laparoscopic extended pelvic lymph node dissection
Overall Study STARTED	11
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Robotic-assisted Laparoscopic Surgery n=11 Participants Robotic-assisted laparoscopic extended pelvic lymph node dissection
Age Continuous	73 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months including surgery and post-operative period.

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.

Outcome measures

Outcome measures
Measure	Robotic-assisted Laparoscopic Surgery n=11 Participants Robotic-assisted laparoscopic extended pelvic lymph node dissection
Median Yield of Robot Assisted and Second Look Open Pelvic Lymph Node Dissection to Compare the Lymph Node Yield Achieved RA-PLND	43 Nodes (Node Yield) Interval 19.0 to 63.0
Median Yield of Robot Assisted and Second Look Open Pelvic Lymph Node Dissection to Compare the Lymph Node Yield Achieved O-PLND	4 Nodes (Node Yield) Interval 0.0 to 8.0

PRIMARY outcome

Timeframe: 3 months including surgery and post-operative period.

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.

Outcome measures

Outcome measures
Measure	Robotic-assisted Laparoscopic Surgery n=11 Participants Robotic-assisted laparoscopic extended pelvic lymph node dissection
Overall Percentage Median Yield RA-PLND	93 Percentage of Nodes (Node Yield)
Overall Percentage Median Yield O-PLND	7 Percentage of Nodes (Node Yield)

Adverse Events

Robotic-assisted Laparoscopic Surgery

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Robotic-assisted Laparoscopic Surgery n=11 participants at risk Robotic-assisted laparoscopic extended pelvic lymph node dissection
Surgical and medical procedures Bowel Leak	9.1% 1/11 • 20 months
Respiratory, thoracic and mediastinal disorders Death	9.1% 1/11 • 20 months

Other adverse events

Other adverse events
Measure	Robotic-assisted Laparoscopic Surgery n=11 participants at risk Robotic-assisted laparoscopic extended pelvic lymph node dissection
Gastrointestinal disorders Ileus	18.2% 2/11 • 20 months

Additional Information

John W. Davis, MD / Assistant Professor

The University of Texas (UT) MD Anderson Cancer Center

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place