We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Microspheres in Preventing Lymphatic Fluid Collection After Surgery in Patients With Prostate Cancer

This study has been terminated.
(PI left institution)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01644136
First Posted: July 18, 2012
Last Update Posted: December 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ohio State University Comprehensive Cancer Center
July 16, 2012
July 18, 2012
December 11, 2017
July 14, 2011
May 6, 2014   (Final data collection date for primary outcome measure)
Incidence of postoperative lymphocele formation [ Time Frame: 3 months after surgery ]
The rate of lymphoceles on each side of the pelvis will be compared. Summary statistics will be reported (mean, standard deviation, and range for the continuous variables and frequency and percentages for the categorical variables). In addition, we will determine interrelationships among specific variables using regression and correlation analyses.
Same as current
Complete list of historical versions of study NCT01644136 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Microspheres in Preventing Lymphatic Fluid Collection After Surgery in Patients With Prostate Cancer
A Pilot Clinical Trial for the Prevention of Postoperative Lymphoceles Using Absorbable Micorporous Polysaccharide Hemosphere Particles During Robotic Assisted Prostatectomy With Lymph Node Dissection
This study is being performed to investigate if the application of Arista absorbable hemostat (AH)®, a product approved to stop surgical bleeding, can prevent lymphoceles. Lymphoceles are collections of lymphatic fluid which can occur after a lymph node dissection for cancer. These fluid collections can become symptomatic in some patients. Arista would be applied to one side of the pelvis after a pelvic lymph node dissection, to see if this decreases the number of postoperative lymph fluid collections seen on a computed tomography (CT) scan after surgery

PRIMARY OBJECTIVES:

I. To determine whether, if applied to the lymph node basins after pelvic lymph node dissection, Arista could potentially reduce the formation of lymphoceles and consequently the need for secondary interventions.

OUTLINE:

Patients undergo standard robotic assisted laparoscopic prostatectomy with pelvic lymph node dissection. After lymph node dissection, patients undergo microsphere-mediated lymphocele prevention to the lymph node basin on one side of the pelvis.

After completion of study treatment, patients are followed up at 3 months.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
  • Lymphocele
  • Prostate Cancer
  • Procedure: robot-assisted laparoscopic surgery
    Undergo standard robotic assisted laparoscopic prostatectomy
  • Procedure: regional lymph node dissection
    Undergo pelvic lymph node dissection
  • Device: microsphere-mediated lymphocele prevention
    Undergo microsphere-mediated lymphocele prevention
Experimental: Supportive care (microsphere-mediated lymphocele prevention)
Patients undergo standard robotic assisted laparoscopic prostatectomy with pelvic lymph node dissection. After lymph node dissection, patients undergo microsphere-mediated lymphocele prevention to the lymph node basin on one side of the pelvis.
Interventions:
  • Procedure: robot-assisted laparoscopic surgery
  • Procedure: regional lymph node dissection
  • Device: microsphere-mediated lymphocele prevention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
99
May 6, 2014
May 6, 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male patients
  • Patients with prostate cancer who are electing to undergo robotic radical prostatectomy with pelvic lymph node dissection at The Arthur G. James Cancer Hospital and Solove Research Institute, The Ohio State University Medical Center by Dr. Ronney Abaza
Sexes Eligible for Study: Male
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01644136
OSU-11017
NCI-2012-00918 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Not Provided
Ohio State University Comprehensive Cancer Center
Ohio State University Comprehensive Cancer Center
Not Provided
Principal Investigator: Ronney Abaza, MD Ohio State University
Ohio State University Comprehensive Cancer Center
December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP