Clinical trial · Interventional
Detection of Lymphnodes Using ICG During RARP
Detection of Lymph Nodes by Means of Intraoperative Fluorescence Lymphography Using Indocyanine Green (ICG) During the Radical Robot-assisted Prostatectomy
NCT02163083CI-TRIAL-00036622completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ICG | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Lymphadenectomy using standard Methods
- description
- Lymphadenectomy will be performed as a standard procedure
- type
- EXPERIMENTAL
- label
- Lymphadenectomy using ICG
- description
- 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.
- interventionNames
- Procedure: ICG
Primary outcomes (1)
- measure
- The total number of detection rate of (positive) lymph nodes using ICG
- timeFrame
- during the surgery
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.