Prostate Cancer Clinical Trial
Official title:
Ultrasound Guided Inguinal Indocyanine Green Injection to Identify and Pre-emptively Seal Lymphatic Leaks
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.
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | February 2026 |
Est. primary completion date | February 2026 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 45 Years to 100 Years |
Eligibility | Inclusion Criteria: - Patient undergoing robotic assisted laparoscopic lymph node dissection Exclusion Criteria: - Patient not undergoing extended lymph node dissection - History of allergy to iodides |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Kaiser Permanente |
Gloger 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-Re — View Citation
Motterle 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. — View Citation
Tewari 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, la — View Citation
Tsaur 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Drain output <100 mL | A sample of 12 recent patients receiving the current standard procedure had a mean drain volume for the first 24 hours of 218 mL and standard deviation of 102. With a hoped-for reduction to <100 mL/ 24 hr mean in the treatment arm, there would be 99% power to detect a difference, and 80% power to detect a difference of 57 mL between treatment and control arms. Given the small sample used for this power estimate, we believe that it is appropriate to power for a range of potential standard deviations and potential differences. | 2 weeks | |
Secondary | Lymphocele formation | Any lymphocele formation will be logged; any lymphocele proven by imaging | 4 weeks |
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