Ultrasound Guided Inguinal Indocyanine Green Injection to Identify and Pre-emptively Seal Lymphatic Leaks
Overview
- Phase
- Phase 4
- Intervention
- ICG injection
- Conditions
- Lymphocele
- Sponsor
- Kaiser Permanente
- Enrollment
- 100
- Primary Endpoint
- Drain output <100 mL
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient undergoing robotic assisted laparoscopic lymph node dissection
Exclusion Criteria
- •Patient not undergoing extended lymph node dissection
- •History of allergy to iodides
Arms & Interventions
ICG Injection
This patient will undergo ICG injection into the lymph nodes in order to see if there are any leaks.
Intervention: ICG injection
ICG Injection
This patient will undergo ICG injection into the lymph nodes in order to see if there are any leaks.
Intervention: Prostatectomy with pelvic lymph node dissection
ICG non-injection
This patient will not have ICG injection. the lymphadenectomy is considered complete at this point.
Intervention: Non-Injection/Control
ICG non-injection
This patient will not have ICG injection. the lymphadenectomy is considered complete at this point.
Intervention: Prostatectomy with pelvic lymph node dissection
Outcomes
Primary Outcomes
Drain output <100 mL
Time Frame: 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 Outcomes
- Lymphocele formation(4 weeks)