NCT06258486

Ultrasound Guided Inguinal Indocyanine Green Injection to Identify and Pre-emptively Seal Lymphatic Leaks

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Kaiser Permanente · Academic / Other
• Sex: Male
• Age: 45 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lymphocele
• Prostate Cancer

Interventions

Type	Name	Description
DRUG	ICG 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.
OTHER	Non-Injection/Control	No ICG injection
PROCEDURE	Prostatectomy with pelvic lymph node dissection	Robotic assisted prostatectomy with pelvic lymph node dissection

Timeline

• Start date: 2024-02-01
• Primary completion: 2026-02-01
• Completion: 2026-02-01
• First posted: 2024-02-14
• Last updated: 2024-02-26

Regulatory

• FDA-regulated drug study