Microspheres in Preventing Lymphatic Fluid Collection After Surgery in Patients With Prostate Cancer
| Status: | Terminated |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 6/30/2018 |
| Start Date: | July 14, 2011 |
| End Date: | May 6, 2014 |
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
(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.
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.
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
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