Detection of Lymphnodes Using ICG During RARP

St. Antonius Hospital Gronau120 enrolled

Overview

The purpose of this study is to investigate, whether the detection of lymph nodes by means of intraoperative fluorescence lymphography as part of lymphadenectomy in robot-assisted radical prostatectomy is higher than without the use of indocyanine green (ICG).

ICG is a fluorescent dye that fluoresces green bound to proteins under illumination in the near-infrared range. Using this dye allows to visualize lymphatic nodes, by being injected into the tumor or directly surrounding tissue.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

120

Conditions

Prostate Cancer

Interventions

ICGPROCEDURE

Improvement of detection of positive lymphnodes

Eligibility

Sex: MALEMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Histologically confirmed locally limited prostate cancer; * Intermediate or high risk tumor * Recommended and planned prostatectomy; * Completed and signed written consent; * Voluntarily agreement to participate in this study * Age of the study participants ≥ 18 years. Exclusion Criteria: * Allergic reaction to active ingredient (indocyanine green); * Iodine allergy; * Hyperthyroidism; * High-grade renal impairment; * High-grade hepatic insufficiency; * Unwillingness to the storage and disclosure of pseudonymous disease and personal data * psychiatric pre-existing conditions or other circumstances that make a cooperation by the patient in question

Locations (1)

St. Antonius Hospital Gronau, Department for Urology, Pediatric Urology and Urologic Oncology

Gronau, Moellenweg 22, Germany

Outcomes

Primary Outcomes

The total number of detection rate of (positive) lymph nodes using ICG

Time frame: during the surgery

Secondary Outcomes

Measurements of the time, that takes to remove the lymph nodes

Time frame: During the surgery

Data from ClinicalTrials.gov

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