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

Phase 4

Not yet recruiting

• Conditions: Lymphocele; Prostate Cancer
• Interventions: Other: Non-Injection/Control; Drug: ICG injection; Procedure: Prostatectomy with pelvic lymph node dissection

• Registration Number: NCT06258486
• Lead Sponsor: Kaiser Permanente

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.

Study Timeline

• Study First Submitted: 2024-01-24
• Status Verified: 2024-02
• Study Start: 2024-02
• Study First Submitted QC: 2024-02-05
• Study First Posted: 2024-02-14
• Last Update Submitted: 2024-02-22
• Last Update Posted: 2024-02-26
• Primary Completion: 2026-02
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 100

Inclusion Criteria

• Patient undergoing robotic assisted laparoscopic lymph node dissection

Exclusion Criteria

• Patient not undergoing extended lymph node dissection
• History of allergy to iodides

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ICG Injection	Prostatectomy with pelvic lymph node dissection	This patient will undergo ICG injection into the lymph nodes in order to see if there are any leaks.
ICG non-injection	Non-Injection/Control	This patient will not have ICG injection. the lymphadenectomy is considered complete at this point.
ICG non-injection	Prostatectomy with pelvic lymph node dissection	This patient will not have ICG injection. the lymphadenectomy is considered complete at this point.
ICG Injection	ICG injection	This patient will undergo ICG injection into the lymph nodes in order to see if there are any leaks.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Lymphocele formation	4 weeks	Any lymphocele formation will be logged; any lymphocele proven by imaging