Clinical trial NCT06258486: Ultrasound Guided Inguinal Indocyanine Green Injection to Identify and Pre-emptively Seal Lymphatic Leaks
Official title: Ultrasound Guided Inguinal Indocyanine Green Injection to Identify and Pre-emptively Seal Lymphatic Leaks
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Lymphocele
Prostate Cancer
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2024-02-14
Enrollment: 100
Sex: MALE
Minimum age (years): 45
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized into ICG versus no ICG injection after pelvic lymphadenectomy is completed.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Patient undergoing robotic assisted laparoscopic lymph node dissection

Exclusion Criteria:

* Patient not undergoing extended lymph node dissection
* History of allergy to iodides

Primary outcomes:
measure: Drain output <100 mL
timeFrame: 2 weeks
Secondary outcomes:
measure: Lymphocele formation
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Kaiser Permanente
name: David Finley, MD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1089/end.2019.0716.
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, laparoscopic, and robotic prostatectomy. Eur Urol. 2012 Jul;62(1):1-15. doi: 10.1016/j.eururo.2012.02.029. Epub 2012 Feb 24.
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.
citation: 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-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.