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Detection of Lymphnodes Using ICG During RARP

Sponsor
St. Antonius Hospital Gronau (Other)
Overall Status
Completed
CT.gov ID
NCT02163083
Collaborator
(none)
120
Enrollment
1
Location
2
Arms
32
Actual Duration (Months)
3.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase
  • Procedure: ICG
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Detection of Lymph Nodes by Means of Intraoperative Fluorescence Lymphography Using Indocyanine Green (ICG) During the Radical Robot-assisted Prostatectomy
Actual Study Start Date :
Aug 1, 2014
Actual Primary Completion Date :
Apr 1, 2015
Actual Study Completion Date :
Apr 1, 2017

Arms and Interventions

Arm Intervention/Treatment
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.

Procedure: ICG
Improvement of detection of positive lymphnodes
Other Names:
  • indocyanine green powder
  • Pulsion Medical Systems, München, Germany

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The total number of detection rate of (positive) lymph nodes using ICG [during the surgery]

    Secondary Outcome Measures

    1. Measurements of the time, that takes to remove the lymph nodes [During the surgery]

    Other Outcome Measures

    1. Determine the anatomical location of the ICG-positive lymph node [During th surgery]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 St. Antonius Hospital Gronau, Department for Urology, Pediatric Urology and Urologic Oncology Gronau Moellenweg 22 Germany 48599

    Sponsors and Collaborators

    • St. Antonius Hospital Gronau

    Investigators

    • Principal Investigator: Jörn H. Witt, MD, St. Antonius Hospital Gronau

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    St. Antonius Hospital Gronau
    ClinicalTrials.gov Identifier:
    NCT02163083
    Other Study ID Numbers:
    • U1111-1157-6624
    • 2013-609-f-S
    First Posted:
    Jun 13, 2014
    Last Update Posted:
    Jan 18, 2019
    Last Verified:
    Jan 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Prostatic Neoplasms

    Study Results

    No Results Posted as of Jan 18, 2019