Detection of Lymphnodes Using ICG During RARP
This trial is active, not recruiting.
|Sponsor||St. Antonius Hospital Gronau|
|Start date||July 2014|
|End date||June 2016|
|Trial size||120 participants|
|Trial identifier||NCT02163083, 2013-609-f-S, U1111-1157-6624|
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).
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
The total number of detection rate of (positive) lymph nodes using ICG
time frame: during the surgery
Measurements of the time, that takes to remove the lymph nodes
time frame: During the surgery
Male participants from 18 years up to 75 years old.
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
|Official title||Detection of Lymph Nodes by Means of Intraoperative Fluorescence Lymphography Using Indocyanine Green (ICG) During the Radical Robot-assisted Prostatectomy|
|Principal investigator||Jörn H. Witt, MD|
|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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