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

Prostate Cancer Clinical Trial

Official title:

A Pilot Clinical Trial for the Prevention of Postoperative Lymphoceles Using Absorbable Micorporous Polysaccharide Hemosphere Particles During Robotic Assisted Prostatectomy With Lymph Node Dissection

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01644136
• Other study ID #: OSU-11017
• Secondary ID: NCI-2012-00918
• Status: Terminated
• Phase: N/A
• Start date: July 14, 2011
• Est. completion date: May 6, 2014

Study information

• Verified date: June 2018
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 99
• Est. completion date: May 6, 2014
• Est. primary completion date: May 6, 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphocele
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Procedure:
• robot-assisted laparoscopic surgery
Undergo standard robotic assisted laparoscopic prostatectomy
• regional lymph node dissection
Undergo pelvic lymph node dissection

Device:
• microsphere-mediated lymphocele prevention
Undergo microsphere-mediated lymphocele prevention

Locations

Country	Name	City	State
United States	The Ohio State University Medical Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of postoperative lymphocele formation	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.	3 months after surgery

External Links

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