NCT02163083
Completed
Not Applicable
Detection of Lymph Nodes by Means of Intraoperative Fluorescence Lymphography Using Indocyanine Green (ICG) During the Radical Robot-assisted Prostatectomy
St. Antonius Hospital Gronau1 site in 1 country120 target enrollmentAugust 2014
ConditionsProstate Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Prostate Cancer
- Sponsor
- St. Antonius Hospital Gronau
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- The total number of detection rate of (positive) lymph nodes using ICG
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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).
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.
Investigators
Eligibility 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
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(During the surgery)
Study Sites (1)
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