Clinical trial · Interventional
Ultrasound Guided Inguinal Indocyanine Green Injection to Identify and Pre-emptively Seal Lymphatic Leaks
NCT06258486CI-TRIAL-00074379unknownPhase 4ClinicalTrials.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)
Goal is to determine whether intraoperative ICG injection can be used to identify and reduce formation of symptomatic lymphoceles in patients receiving robot-assisted prostatectomy.
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 |
|---|---|---|---|
| Lymphocele | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ICG injection | Drug | — | UNRESOLVED |
| Non-Injection/Control | Other | — | UNRESOLVED |
| Prostatectomy with pelvic lymph node dissection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ICG Injection
- description
- This patient will undergo ICG injection into the lymph nodes in order to see if there are any leaks.
- interventionNames
- Drug: ICG injection
- Procedure: Prostatectomy with pelvic lymph node dissection
- type
- PLACEBO_COMPARATOR
- label
- ICG non-injection
- description
- This patient will not have ICG injection. the lymphadenectomy is considered complete at this point.
- interventionNames
- Other: Non-Injection/Control
- Procedure: Prostatectomy with pelvic lymph node dissection
Primary outcomes (1)
- measure
- Drain output <100 mL
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 45 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * Patient undergoing robotic assisted laparoscopic lymph node dissection Exclusion Criteria: * Patient not undergoing extended lymph node dissection * History of allergy to iodides
References
Publications (4)
- RESULTMotterle G, Morlacco A, Zanovello N, Ahmed ME, Zattoni F, Karnes RJ, Dal Moro F. Surgical Strategies for Lymphocele Prevention in Minimally Invasive Radical Prostatectomy and Lymph Node Dissection: A Systematic Review. J Endourol. 2020 Feb;34(2):113-120. doi: 10.1089/end.2019.0716. PMID 31797684
- RESULTTewari A, Sooriakumaran P, Bloch DA, Seshadri-Kreaden U, Hebert AE, Wiklund P. Positive surgical margin and perioperative complication rates of primary surgical treatments for prostate cancer: a systematic review and meta-analysis comparing retropubic, laparoscopic, and robotic prostatectomy. Eur Urol. 2012 Jul;62(1):1-15. doi: 10.1016/j.eururo.2012.02.029. Epub 2012 Feb 24. PMID 22405509
- RESULTTsaur I, Thomas C. Risk factors, complications and management of lymphocele formation after radical prostatectomy: A mini-review. Int J Urol. 2019 Jul;26(7):711-716. doi: 10.1111/iju.13964. Epub 2019 Apr 2. PMID 30939628
- RESULTGloger S, Ubrig B, Boy A, Leyh-Bannurah SR, Siemer S, Arndt M, Stolzenburg JU, Franz T, Oelke M, Witt JH. Bilateral Peritoneal Flaps Reduce Incidence and Complications of Lymphoceles after Robotic Radical Prostatectomy with Pelvic Lymph Node Dissection-Results of the Prospective Randomized Multicenter Trial ProLy. J Urol. 2022 Aug;208(2):333-340. doi: 10.1097/JU.0000000000002693. Epub 2022 Apr 15. PMID 35422136