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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICG Injection | Experimental | This patient will undergo ICG injection into the lymph nodes in order to see if there are any leaks. |
|
| ICG non-injection | Placebo Comparator | This patient will not have ICG injection. the lymphadenectomy is considered complete at this point. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICG injection | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Lymphocele formation | Any lymphocele formation will be logged; any lymphocele proven by imaging | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David Finley, MD | Contact | 310-210-4555 | david.s.finley@kp.org | |
| Irene Chen, MD | Contact | 323-783-2065 | irene.k.chen@kp.org |
| Name | Affiliation | Role |
|---|---|---|
| David Finley, MD | Kaiser Permanente | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31797684 | Result | 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. | |
| 22405509 | Result | 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. |
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No indication to share individual participant data with other researchers.
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| ID | Term |
|---|---|
| D008210 | Lymphocele |
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D003560 | Cysts |
| D009369 | Neoplasms |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D011468 | Prostatectomy |
| ID | Term |
|---|---|
| D013521 | Urologic Surgical Procedures, Male |
| D013520 | Urologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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Patients will be randomized into ICG versus no ICG injection after pelvic lymphadenectomy is completed.
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The investigator and participant will not know which arm the patient is randomized into while undergoing the surgery. It isn't until the surgery is complete that the patient will be randomized into either ICG injection versus not.
| Non-Injection/Control | Other | No ICG injection |
|
| Prostatectomy with pelvic lymph node dissection | Procedure | Robotic assisted prostatectomy with pelvic lymph node dissection |
|
| 30939628 | Result | 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. |
| 35422136 | Result | 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. |
| D005834 |
| Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |