Detection of Lymphnodes Using ICG During RARP

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).

Full Title of Study: “Detection of Lymph Nodes by Means of Intraoperative Fluorescence Lymphography Using Indocyanine Green (ICG) During the Radical Robot-assisted Prostatectomy”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2015

Detailed Description

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.

Interventions

  • Procedure: ICG
    • Improvement of detection of positive lymphnodes

Arms, Groups and Cohorts

  • No Intervention: Lymphadenectomy using standard Methods
    • Lymphadenectomy will be performed as a standard procedure
  • Experimental: Lymphadenectomy using ICG
    • A fluorescent dye (indocyanine green) will be ultrasound-controlled preoperatively injected in the prostate. During robot-assisted radical intervention by DaVinci ® robot the lymphadenectomy is performed using the fluorescence lymphography.

Clinical Trial Outcome Measures

Primary Measures

  • The total number of detection rate of (positive) lymph nodes using ICG
    • Time Frame: during the surgery

Secondary Measures

  • Measurements of the time, that takes to remove the lymph nodes
    • Time Frame: During the surgery

Participating in This Clinical Trial

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

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • St. Antonius Hospital Gronau
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jörn H. Witt, MD, Principal Investigator, St. Antonius Hospital Gronau

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