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

Primary Purpose

Lymphocele, Prostate Cancer

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
robot-assisted laparoscopic surgery
regional lymph node dissection
microsphere-mediated lymphocele prevention
Sponsored by
Ohio State University Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Lymphocele

Eligibility Criteria

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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

Sites / Locations

  • The Ohio State University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Supportive care (microsphere-mediated lymphocele prevention)

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
July 16, 2012
Last Updated
June 26, 2018
Sponsor
Ohio State University Comprehensive Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT01644136
Brief Title
Microspheres in Preventing Lymphatic Fluid Collection After Surgery in Patients With Prostate Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Terminated
Why Stopped
PI left institution
Study Start Date
July 14, 2011 (Actual)
Primary Completion Date
May 6, 2014 (Actual)
Study Completion Date
May 6, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ohio State University Comprehensive Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphocele, Prostate Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
99 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Supportive care (microsphere-mediated lymphocele prevention)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
robot-assisted laparoscopic surgery
Intervention Description
Undergo standard robotic assisted laparoscopic prostatectomy
Intervention Type
Procedure
Intervention Name(s)
regional lymph node dissection
Intervention Description
Undergo pelvic lymph node dissection
Intervention Type
Device
Intervention Name(s)
microsphere-mediated lymphocele prevention
Intervention Description
Undergo microsphere-mediated lymphocele prevention
Primary Outcome Measure Information:
Title
Incidence of postoperative lymphocele formation
Description
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.
Time Frame
3 months after surgery

10. Eligibility

Sex
Male
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronney Abaza, MD
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

Links:
URL
http://cancer.osu.edu
Description
Jamesline

Learn more about this trial

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

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