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Detection of Lymphnodes Using ICG During RARP

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ClinicalTrials.gov Identifier: NCT02163083
Recruitment Status : Completed
First Posted : June 13, 2014
Last Update Posted : January 18, 2019
Sponsor:
Information provided by (Responsible Party):
St. Antonius Hospital Gronau

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
Prostate Cancer Procedure: ICG Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : August 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. The total number of detection rate of (positive) lymph nodes using ICG [ Time Frame: during the surgery ]

Secondary Outcome Measures :
  1. Measurements of the time, that takes to remove the lymph nodes [ Time Frame: During the surgery ]

Other Outcome Measures:
  1. Determine the anatomical location of the ICG-positive lymph node [ Time Frame: During th surgery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02163083


Locations
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Germany
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
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Principal Investigator: Jörn H. Witt, MD St. Antonius Hospital Gronau
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Responsible Party: St. Antonius Hospital Gronau
ClinicalTrials.gov Identifier: NCT02163083    
Other Study ID Numbers: U1111-1157-6624
2013-609-f-S ( Other Identifier: ethical review committee )
First Posted: June 13, 2014    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases