Clinical trial · Interventional
Use of Indocyanine Green During Pelvic Lymph Node Dissection in Prostate Cancer.
Is the Extended Lymph Node Dissection Under Indocyanine Green (ICG) Based Fluorescence Imaging Superior to Conventional Extended Lymph Node Dissection During Laparoscopic Radical Prostatectomy(LRRP)?
- 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)
Standard treatment of local or locally advanced prostate cancer is radical prostatectomy (RRP) surgery. During RRP in certain patients extended lymph node dissection (ELND) is recommended. to detect eligible patients for ELND some nomograms based on clinical factors of them is used. The Briganti nomogram is one of them. If the patient has 7% or more probability on Briganti nomogram, then ELND is recommended. But ELND is complicated surgical procedure and may cause labor lost and cost. It is aimed here to show whether the ICG based fluorescence imaging during laparoscopy may yield higher accuracy to detect metastatic LNs than the conventional ELND?
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymph Node Metastases | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Indocyanine green | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ICG group
- description
- ICG injection before LRRP via cystoscopy
- interventionNames
- Drug: Indocyanine green
Primary outcomes (4)
- measure
- Indocyanine green postive lymph node numbers
- timeFrame
- 15 day after surgery
- description
- total number of dissected lymph nodes which are indocyanine green positive
- measure
- Total lymph node numbers of conventional extended lymph node dissection
- timeFrame
- 15 day after surgery
- description
- total number of dissected lymph nodes during conventional extended lymph node dissection
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