Ultrasound Guided Inguinal Indocyanine Green Injection to Identify and Pre-emptively Seal Lymphatic Leaks

Prostate Cancer Clinical Trial

Official title:

Ultrasound Guided Inguinal Indocyanine Green Injection to Identify and Pre-emptively Seal Lymphatic Leaks

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06258486
• Other study ID #: ICG lymphatic
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: February 2024
• Est. completion date: February 2026

Study information

• Verified date: February 2024
• Source: Kaiser Permanente
• Contact: David Finley, MD
• Phone: 310-210-4555
• Email: david.s.finley[@]kp.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

The goal of this clinical trial is to determine whether intraoperative ICG injection can be used to identify and reduce formation of symptomatic lymphoceles in patients receiving robot-assisted prostatectomy. The main question is if it could improve patients' quality of life and infection risk post-surgery. It would also help to decrease emergency room visits as well as additional procedures. Researchers will compare those who receive the ICG and those who do not. Patients will be randomized into the ICG arm versus no ICG arm after pelvic lymphadenectomy is done.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Lymphocele
• Prostate Cancer

Intervention

Drug:
• ICG injection
Patient will have a green dye (ICG) injected into the lymph node to better visualize non-sealed leaks in order to pre-emptively seal any lymphatic leaks.

Other:
• Non-Injection/Control
No ICG injection

Procedure:
• Prostatectomy with pelvic lymph node dissection
Robotic assisted prostatectomy with pelvic lymph node dissection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kaiser Permanente

References & Publications (4)

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

Outcome

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