Lymphocele, Prostate Cancer
Conditions
Brief summary
Goal is to determine whether intraoperative ICG injection can be used to identify and reduce formation of symptomatic lymphoceles in patients receiving robot-assisted prostatectomy.
Detailed description
The goal of this clinical trial is to determine whether intraoperative ICG injection can be used to identify and reduce formation of symptomatic lymphoceles in patients receiving robot-assisted prostatectomy. The main question is if it could improve patients' quality of life and infection risk post-surgery. It would also help to decrease emergency room visits as well as additional procedures. Researchers will compare those who receive the ICG and those who do not. Patients will be randomized into the ICG arm versus no ICG arm after pelvic lymphadenectomy is done.
Interventions
DRUGICG injection
Patient will have a green dye (ICG) injected into the lymph node to better visualize non-sealed leaks in order to pre-emptively seal any lymphatic leaks.
OTHERNon-Injection/Control
No ICG injection
PROCEDUREProstatectomy with pelvic lymph node dissection
Robotic assisted prostatectomy with pelvic lymph node dissection
Sponsors
Kaiser Permanente
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
The investigator and participant will not know which arm the patient is randomized into while undergoing the surgery. It isn't until the surgery is complete that the patient will be randomized into either ICG injection versus not.
Intervention model description
Patients will be randomized into ICG versus no ICG injection after pelvic lymphadenectomy is completed.
Eligibility
Sex/Gender
MALE
Age
45 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Patient undergoing robotic assisted laparoscopic lymph node dissection
Exclusion criteria
* Patient not undergoing extended lymph node dissection * History of allergy to iodides
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Drain output <100 mL | 2 weeks | A sample of 12 recent patients receiving the current standard procedure had a mean drain volume for the first 24 hours of 218 mL and standard deviation of 102. With a hoped-for reduction to \<100 mL/ 24 hr mean in the treatment arm, there would be 99% power to detect a difference, and 80% power to detect a difference of 57 mL between treatment and control arms. Given the small sample used for this power estimate, we believe that it is appropriate to power for a range of potential standard deviations and potential differences. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lymphocele formation | 4 weeks | Any lymphocele formation will be logged; any lymphocele proven by imaging |
Contacts
Primary ContactDavid Finley, MD
Backup ContactIrene Chen, MD
Outcome results
None listed