Prostate Cancer
Conditions
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.
Interventions
PROCEDUREICG
Improvement of detection of positive lymphnodes
Sponsors
St. Antonius Hospital Gronau
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The total number of detection rate of (positive) lymph nodes using ICG | during the surgery |
Secondary
| Measure | Time frame |
|---|---|
| Measurements of the time, that takes to remove the lymph nodes | During the surgery |
Other
| Measure | Time frame |
|---|---|
| Determine the anatomical location of the ICG-positive lymph node | During th surgery |
Countries
Germany
Outcome results
None listed