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

Kaiser Permanente

Status and phase: Not yet enrolling; Phase 4

Conditions: Lymphocele; Prostate Cancer

Treatments: Procedure: Prostatectomy with pelvic lymph node dissection; Other: Non-Injection/Control; Drug: ICG injection

Study type: Interventional

Funder types: Other

Identifiers

NCT06258486

ICG lymphatic

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Male

Ages: 45 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient undergoing robotic assisted laparoscopic lymph node dissection

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

ICG Injection

Experimental group

Description:

This patient will undergo ICG injection into the lymph nodes in order to see if there are any leaks.

Treatment:

Procedure: Prostatectomy with pelvic lymph node dissection

Drug: ICG injection

ICG non-injection

Placebo Comparator group

Description:

This patient will not have ICG injection. the lymphadenectomy is considered complete at this point.

Treatment:

Other: Non-Injection/Control

Procedure: Prostatectomy with pelvic lymph node dissection